Companies / Advanced Orthopaedic Solutions (AOS)

Medical device company profile

Advanced Orthopaedic Solutions (AOS)

Orthopedic trauma implants, intramedullary nails, fracture plates, screws and external fixation systems.

Medical Device ManufacturerOrthopedics & MusculoskeletalBone Repair & Reconstruction

Headquarters🇺🇸Torrance, California, United States

Founded2001

Commercial statusCommercially availableU.S. commercial portfolio; availability varies by product and configuration.

EmployeesNot confirmed

Estimated revenueNot confirmed

Official websitewww.aosortho.com ↗

Company overview

Advanced Orthopaedic Solutions (AOS) designs, manufactures and markets orthopedic trauma implants and instruments. Founded in 2001 and headquartered in Torrance, California, it specializes in intramedullary fixation and related systems for fracture care.

The portfolio spans Galileo trochanteric nails, Magellan femoral nails, Da Vinci tibial nails, Newton humeral nails and fibular nails, together with Fibonacci lower-extremity plates, proximal humeral and clavicle systems, external fixation and cannulated screws. Its systems support upper- and lower-extremity trauma procedures.

The company’s published management page identifies Gary Sohngen as founder and president and Michael Payne as founder and vice president of sales and marketing. Omni Orthopedics names AOS among its represented manufacturers on its president’s professional profile; product-specific rights and manufacturer confirmation have not been established.

^{[13][14][15][68][69]}

Leadership

3 people

Gary SohngenFounder and President (company-listed) ^[13]

Michael PayneFounder and Vice President of Sales & Marketing (company-listed) ^[13]

Kazu MiyaharaDirector of Research & Development (company-listed) ^[13]

Products & regulatory status How does MedTechIndex get this information?

Summary

The reviewed FDA applicant records contain 28 distinct 510(k) decisions. Twenty-seven are mapped at family level to the displayed commercial portfolio; K141228 for a 6.5 mm captured cancellous screw remains outside the current totals because its relationship to the current 7.0 mm offering was not established. Shared manufacturing and component decisions are counted once. No matching De Novo grants or original PMA approvals were identified in the reviewed applicant and product searches. ^[31][43][34]

FDA records document one historical Class II recall event (54538), represented by 12 recall numbers for specified legacy AOS Trochanteric Nails. It was initiated January 14, 2010 after an incorrectly bent nail was found, and is listed as terminated. These affected legacy models have not been matched to the current marketed Galileo configurations and are excluded from the current-portfolio recall total. No open AOS recall event was identified in the reviewed firm-name and FEI searches. ^{[17][35][58][59][60][61][62][63][64][65][66][67]}

Regulatory snapshot How to read this snapshot

U.S. FDA

27
510(k) clearances: 0
De Novo grants: 0
PMA approvals: 0
Recall events

Lower-extremity plates and screw options, including ankle and proximal tibial applications. ^[22]

A modular femoral nail using interchangeable inserts for antegrade, retrograde, reconstruction and other configurations. ^[28]

FDA-cleared

Listed in the manufacturer’s current U.S. portfolio.

Known Distribution Partners

1 partner

Publicly documented relationships; coverage may be incomplete.

Partner	Territory / scope	Products
Omni Orthopedics, Inc. (distributor-reported) ^[70]	Ohio and Kentucky (reported service area; manufacturer-specific territory unconfirmed)	AOS portfolio representation; specific products not established

Sources checked October 22, 2026.

70 Cited Sources

Accessed 10/28/2026

Last substantive review: 10/22/2026

[1] FDA recall Z-118-2010 ↗U.S. Food and Drug Administration · regulatory

[2] FDA recall Z-1181-2010 ↗U.S. Food and Drug Administration · regulatory

[3] FDA recall Z-1182-2010 ↗U.S. Food and Drug Administration · regulatory

[4] FDA recall Z-1183-2010 ↗U.S. Food and Drug Administration · regulatory

[5] FDA recall Z-1184-2010 ↗U.S. Food and Drug Administration · regulatory

[6] FDA recall Z-1186-2010 ↗U.S. Food and Drug Administration · regulatory

[7] FDA recall Z-1187-2010 ↗U.S. Food and Drug Administration · regulatory

[8] FDA recall Z-1188-2010 ↗U.S. Food and Drug Administration · regulatory

[9] FDA recall Z-1189-2010 ↗U.S. Food and Drug Administration · regulatory

[10] FDA recall Z-1190-2010 ↗U.S. Food and Drug Administration · regulatory

[11] FDA recall Z-1191-2010 ↗U.S. Food and Drug Administration · regulatory

[12] FDA recall Z-1192-2010 ↗U.S. Food and Drug Administration · regulatory

[13] AOS company history and management ↗Advanced Orthopaedic Solutions · company website

[14] AOS office — Torrance, California ↗Advanced Orthopaedic Solutions · company website

[15] AOS current product portfolio ↗Advanced Orthopaedic Solutions · company website

[16] Galileo Trochanteric Nail System — official product information ↗Advanced Orthopaedic Solutions (AOS) · company website

[17] FDA Z-118-2010 — specified legacy AOS Trochanteric Nail ↗U.S. Food and Drug Administration · regulatory database

[18] Magellan Femoral Nail System — official product information ↗Advanced Orthopaedic Solutions (AOS) · company website

[19] Da Vinci Tibial Nail System — official product information ↗Advanced Orthopaedic Solutions (AOS) · company website

[20] Newton Humeral Nail System — official product information ↗Advanced Orthopaedic Solutions (AOS) · company website

[21] Fibular Nail System — official product information ↗Advanced Orthopaedic Solutions (AOS) · company website

[22] Fibonacci Lower Extremity Plating System — official product information ↗Advanced Orthopaedic Solutions (AOS) · company website

[23] Proximal Humeral Plating System — official product information ↗Advanced Orthopaedic Solutions (AOS) · company website

[24] Clavicle System — official product information ↗Advanced Orthopaedic Solutions (AOS) · company website

[25] Large Bone Temporary External Fixation — official product information ↗Advanced Orthopaedic Solutions (AOS) · company website

[26] Small Bone External Fixation — official product information ↗Advanced Orthopaedic Solutions (AOS) · company website

[27] 7.0 mm Cannulated Screw System — official product information ↗Advanced Orthopaedic Solutions (AOS) · company website

[28] Modular Femoral System — official product information ↗Advanced Orthopaedic Solutions (AOS) · company website

[29] FDA K160409 — AOS Anterolateral Proximal Humeral Plate ↗U.S. Food and Drug Administration · regulatory database

[30] FDA K133081 — TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N ↗U.S. Food and Drug Administration · regulatory database

[31] FDA K202099 — AOS Galileo Trochanteric Nail System ↗U.S. Food and Drug Administration · regulatory database

[32] FDA K191598 — AOS ES Retrograde Femoral Nail ↗U.S. Food and Drug Administration · regulatory database

[33] FDA K163014 — AOS Small Bone Nailing System ↗U.S. Food and Drug Administration · regulatory database

[34] FDA K141228 — AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW ↗U.S. Food and Drug Administration · regulatory database

[35] FDA Z-1181-2010 — specified legacy AOS Trochanteric Nail ↗U.S. Food and Drug Administration · regulatory database

[36] FDA K143204 — AOS Clavicle Intramedullary Device ↗U.S. Food and Drug Administration · regulatory database

[37] FDA K161913 — AOS Small Fragment Plating System ↗U.S. Food and Drug Administration · regulatory database

[38] FDA K050241 — AOS HUMERAL NAIL ↗U.S. Food and Drug Administration · regulatory database

[39] FDA K080590 — AOS PROXIMAL HUMERAL PLATE ↗U.S. Food and Drug Administration · regulatory database

[40] FDA K132005 — RETROGRADE FEMORAL NAIL ↗U.S. Food and Drug Administration · regulatory database

[41] FDA K123569 — ANTEGRADE FEMORAL NAIL ↗U.S. Food and Drug Administration · regulatory database

[42] FDA K122623 — SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT ↗U.S. Food and Drug Administration · regulatory database

[43] FDA K202489 — AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating System ↗U.S. Food and Drug Administration · regulatory database

[44] FDA K080408 — EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD ↗U.S. Food and Drug Administration · regulatory database

[45] FDA K120148 — AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW ↗U.S. Food and Drug Administration · regulatory database

[46] FDA K130625 — 12MM AND 13MM TIBIAL NAILS ↗U.S. Food and Drug Administration · regulatory database

[47] FDA K171606 — AOS Anterolateral Proximal Humeral Plate ↗U.S. Food and Drug Administration · regulatory database

[48] FDA K090478 — AOS PROXIMAL HUMERAL NAIL ↗U.S. Food and Drug Administration · regulatory database

[49] FDA K103533 — ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM ↗U.S. Food and Drug Administration · regulatory database

[50] FDA K070444 — AOS TIBIAL NAIL ↗U.S. Food and Drug Administration · regulatory database

[51] FDA K103513 — LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA ↗U.S. Food and Drug Administration · regulatory database

[52] FDA K012190 — AOS MODULAR FEMORAL NAIL ↗U.S. Food and Drug Administration · regulatory database

[53] FDA K141912 — AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON ↗U.S. Food and Drug Administration · regulatory database

[54] FDA K182466 — AOS Calcaneal Plating System ↗U.S. Food and Drug Administration · regulatory database

[55] FDA K181035 — AOS Small Fragment Plating System Lite ↗U.S. Food and Drug Administration · regulatory database

[56] FDA K014185 — AOS CANNULATED BONE SCREW SYSTEM ↗U.S. Food and Drug Administration · regulatory database

[57] FDA K021008 — ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL ↗U.S. Food and Drug Administration · regulatory database

[58] FDA Z-1182-2010 — specified legacy AOS Trochanteric Nail ↗U.S. Food and Drug Administration · regulatory database

[59] FDA Z-1183-2010 — specified legacy AOS Trochanteric Nail ↗U.S. Food and Drug Administration · regulatory database

[60] FDA Z-1184-2010 — specified legacy AOS Trochanteric Nail ↗U.S. Food and Drug Administration · regulatory database

[61] FDA Z-1186-2010 — specified legacy AOS Trochanteric Nail ↗U.S. Food and Drug Administration · regulatory database

[62] FDA Z-1187-2010 — specified legacy AOS Trochanteric Nail ↗U.S. Food and Drug Administration · regulatory database

[63] FDA Z-1188-2010 — specified legacy AOS Trochanteric Nail ↗U.S. Food and Drug Administration · regulatory database

[64] FDA Z-1189-2010 — specified legacy AOS Trochanteric Nail ↗U.S. Food and Drug Administration · regulatory database

[65] FDA Z-1190-2010 — specified legacy AOS Trochanteric Nail ↗U.S. Food and Drug Administration · regulatory database

[66] FDA Z-1191-2010 — specified legacy AOS Trochanteric Nail ↗U.S. Food and Drug Administration · regulatory database

[67] FDA Z-1192-2010 — specified legacy AOS Trochanteric Nail ↗U.S. Food and Drug Administration · regulatory database

[68] FDA De Novo applicant search — no matching published decisions ↗U.S. Food and Drug Administration · regulatory database

[69] FDA PMA database — applicant and selected product searches ↗U.S. Food and Drug Administration · regulatory database

[70] Chip Smith — Omni manufacturer portfolio and Ohio/Kentucky service area (self-reported; contract unconfirmed) ↗Chip Smith / LinkedIn · professional profile