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Companies / Total Joint Orthopedics (TJO)
Medical device company profile

Total Joint Orthopedics (TJO)

Hip and knee replacement implants, including Klassic primary and revision systems, Platform acetabular components and Aurum bearing technology.

Medical Device ManufacturerOrthopedics & MusculoskeletalJoint Reconstruction
Headquarters🇺🇸Salt Lake City, Utah, United States
Founded2009
Commercial statusCommercially availableU.S. commercial portfolio; availability varies by product and configuration.
EmployeesNot confirmed
Estimated revenueNot confirmed
Disclosed fundingUp to US$11 million [43]Debt facility · Oct 2026
Official websitewww.tjoinc.com ↗

Company overview

Total Joint Orthopedics (TJO) is a privately held orthopedic implant manufacturer based in Salt Lake City, Utah. Founded in 2009, the company develops hip and knee replacement systems for hospitals and ambulatory surgery centers. Co-founder Aaron Hofmann serves as chairman and Erin Hofmann is chief executive officer.

Its portfolio includes Klassic primary and revision knee systems, Klassic HD hip components, Platform acetabular components and Klassic BiPolar heads. Aurum uses a titanium nitride surface treatment on selected femoral components. Product configurations and labeling vary; robotic compatibility is provided through a separate THINK Surgical platform.

On October 21, 2026, TJO announced a debt financing facility of up to $11 million to expand inventory, instrumentation and distribution, and advance porous and revision Aurum designs and a next-generation hip stem. The company also supports Operation Walk through implant donations.

[1][2][36][38][43][44]

Leadership

3 people
Erin HofmannChief Executive Officer [43]
Aaron Hofmann, MDCo-Founder and Chairman [43]
Vito N. GuardiaVice President of Commercial [42]

Products & regulatory status How does MedTechIndex get this information?

Summary

FDA records document 30 distinct 510(k) decisions mapped to the current hip, knee and bipolar families, including records filed under the misspelled applicant “Total Joint Othopedics.” A separate July 2026 clearance for the Klassic Infection Spacer System is retained outside the commercial totals because launch availability was not established. No matching De Novo grants or original PMA approvals were identified in the reviewed applicant and product searches. [32][33]

FDA lists an open Class II recall for specified Klassic BiPolar Heads (Z-0432-2026; event 97708), initiated September 23, 2025 and posted November 5, 2025. The stated issue is packaging that may compromise the sterile barrier. The recall covers the specified head inventory, not all TJO hip and knee implants; FDA instructs consignees to stop implanting and return affected products. [34]

Regulatory snapshot How to read this snapshot

U.S. FDA
30
510(k) clearances
0
De Novo grants
0
PMA approvals
1
Recall events

Latest recorded source review: 2026-10-22.

View 1 documented open recall event
Documented open FDA recall events
Recalled product / recordInitiatedSource
  • Klassic BiPolar HeadZ-0432-2026
September 23, 2025[34][35]

Commercial portfolio snapshot

Documented commercial product families.

Klassic Knee System
Image: Total Joint Orthopedics (TJO)
Orthopedic implant system

Klassic Knee System ↗

Primary knee replacement components, including CR/Ultra-PS and PS-Post options, tibial inserts, patellae and selected Aurum femoral components. [41]

FDA-cleared

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

Klassic Revision Knee System
Image: Total Joint Orthopedics (TJO)
Orthopedic implant system

Klassic Revision Knee System ↗

Revision knee implants, stems, augments and Universal cones, with Klassic ONE instrumentation. Individual configurations have their own labeling. [40]

FDA-cleared

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

Klassic HD Hip / Platform Acetabular Systems
Image: Total Joint Orthopedics (TJO)
Orthopedic implant system

Klassic HD Hip / Platform Acetabular Systems ↗

Femoral stems and heads, acetabular cups and polyethylene liners for hip replacement, including Platform and selected BIOLOX ceramic head options. [39]

FDA-cleared

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

Klassic BiPolar System
Image: Total Joint Orthopedics (TJO)
Orthopedic implant system

Klassic BiPolar System ↗

Bipolar heads for hip hemiarthroplasty. Specified BiPolar Heads are subject to FDA recall Z-0432-2026; consult the recall for affected inventory. [39]

FDA-cleared

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

Products with unconfirmed commercial availability

Orthopedic implant system

Klassic Infection Spacer System ↗

FDA-cleared infection spacer system documented in K261734. Commercial launch and availability were not established in the reviewed manufacturer material. [33]

Commercial availability not established

FDA clearance documented; commercial launch and availability not established.

Commercial development

TJO’s October 21, 2026 financing announcement describes planned investment in porous and revision Aurum designs, a next-generation hip stem, and distribution expansion. These development statements do not establish additional FDA clearances or launch dates. [43]

Known Distribution Partners

1 partner

Publicly documented relationships; coverage may be incomplete.

PartnerTerritory / scopeProducts
Omni Orthopedics, Inc. (distributor-reported) [45]Ohio and Kentucky (reported service area; manufacturer-specific territory unconfirmed)Hip and knee implants; specific models not established

Sources checked October 22, 2026.

Activity & Milestones

1 events
2026-10-21 · Financing & Expansion

Growth financing announced

TJO announced a debt financing facility of up to $11 million to support inventory, instrumentation, distribution and product development. [43]

45 Cited Sources

Accessed 10/29/2026

Last substantive review: 10/22/2026

[1] FDA PMA database — applicant and selected product searches ↗U.S. Food and Drug Administration · regulatory database
[2] FDA De Novo applicant search — no matching published decisions ↗U.S. Food and Drug Administration · regulatory database
[3] FDA K100445 — KLASSIC HD HIP SYSTEM ↗U.S. Food and Drug Administration · regulatory database
[4] FDA K112906 — KLASSIC KNEE SYSTEM ↗U.S. Food and Drug Administration · regulatory database
[5] FDA K131454 — KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD ↗U.S. Food and Drug Administration · regulatory database
[7] FDA K140942 — KLASSIC KNEE TIBIAL STEM EXTENSION ↗U.S. Food and Drug Administration · regulatory database
[8] FDA K141972 — KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY ↗U.S. Food and Drug Administration · regulatory database
[9] FDA K143113 — Klassic BiPolar System ↗U.S. Food and Drug Administration · regulatory database
[10] FDA K143407 — Klassic HD Hip System ↗U.S. Food and Drug Administration · regulatory database
[11] FDA K150105 — Klassic Knee System-Sombrero Patella ↗U.S. Food and Drug Administration · regulatory database
[12] FDA K151440 — Klassic HD Hip System ↗U.S. Food and Drug Administration · regulatory database
[13] FDA K153075 — Klassic Knee System ↗U.S. Food and Drug Administration · regulatory database
[14] FDA K153310 — Klassic Knee System ↗U.S. Food and Drug Administration · regulatory database
[15] FDA K161073 — Klassic HD Hip System ↗U.S. Food and Drug Administration · regulatory database
[16] FDA K162256 — Klassic Femur, Porous, Klassic Tibial Baseplate, Porous ↗U.S. Food and Drug Administration · regulatory database
[17] FDA K162422 — Klassic Knee System ↗U.S. Food and Drug Administration · regulatory database
[18] FDA K171962 — Klassic HD® Hip System ↗U.S. Food and Drug Administration · regulatory database
[20] FDA K180159 — Klassic® Knee System ↗U.S. Food and Drug Administration · regulatory database
[21] FDA K180929 — Klassic HD® Hip System ↗U.S. Food and Drug Administration · regulatory database
[24] FDA K191399 — BIOLOX CONTOURA Ceramic Femoral Head ↗U.S. Food and Drug Administration · regulatory database
[25] FDA K202740 — Klassic Knee System Tibial Inserts, PS-Max ↗U.S. Food and Drug Administration · regulatory database
[26] FDA K211602 — Klassic Knee System ↗U.S. Food and Drug Administration · regulatory database
[27] FDA K211877 — Klassic Knee System ↗U.S. Food and Drug Administration · regulatory database
[29] FDA K220483 — Platform® Acetabular System ↗U.S. Food and Drug Administration · regulatory database
[30] FDA K230537 — Klassic Knee Revision System ↗U.S. Food and Drug Administration · regulatory database
[32] FDA K243991 — Klassic Knee System - Revision Tibial Baseplate ↗U.S. Food and Drug Administration · regulatory database
[33] FDA K261734 — Klassic Infection Spacer System ↗U.S. Food and Drug Administration · regulatory database
[34] FDA Z-0432-2026 — Klassic BiPolar Head ↗U.S. Food and Drug Administration · regulatory database
[35] FDA recall Z-0432-2026 ↗U.S. Food and Drug Administration · regulatory
[36] About TJO ↗Total Joint Orthopedics · company website
[38] TJO headquarters ↗Total Joint Orthopedics · company website
[40] Klassic Revision Knee System — official product information ↗Total Joint Orthopedics (TJO) · company website
[41] Klassic Knee System — official product information ↗Total Joint Orthopedics (TJO) · company website
[42] TJO appoints Vito Guardia as VP of Commercial ↗Total Joint Orthopedics · press release · Published 2026-03-03
[43] TJO announces growth financing of up to $11 million ↗Total Joint Orthopedics · press release · Published 2026-10-21
[44] TJO and THINK Surgical collaboration; founding in 2009 ↗Total Joint Orthopedics · press release · Published 2020-09-23
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