Planning and navigation
Intellijoint HIP ↗
Intraoperative navigation measurements for total hip arthroplasty. [20][22]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Companies / Intellijoint Surgical
Medical device company profile
Intellijoint Surgical
Surgical planning and navigation technology for hip and knee replacement.
Medical Device ManufacturerOrthopedics & MusculoskeletalJoint ReconstructionCommercial-stage
Company overview
Intellijoint Surgical is a Canadian orthopedic technology company founded in 2010. Its systems provide surgeons with planning tools and intraoperative measurements during joint replacement, supporting implant positioning without prescribing a single implant brand.
Intellijoint HIP and KNEE address navigation during arthroplasty, while Intellijoint VIEW supports preoperative planning. The selected FDA decisions cover separate navigation and planning products; clearance is not evidence that every software version or workflow has the same indication.
Co-founder Armen Bakirtzian leads the company. An October 2026 FDA recall posting concerns eight specified older navigation workstations using affected Apple laptops; the issue is battery overheating and fire risk, rather than a company-wide finding about navigation accuracy.
Leadership
3 peopleArmen BakirtzianCEO & Co-Founder [21]
Andre HladioCTO & Co-Founder [21]
Richard FansonChief Science Officer & Co-Founder [21]
Products & regulatory status How does MedTechIndex get this information?
Summary
Intellijoint HIP and its navigation software have multiple 510(k) decisions, including earlier HIP generations missing from the former snapshot. The current portfolio includes navigation and planning products, while recall scope depends on specific software or workstation versions rather than the entire platform. [20][6][3][21][1]
The matched FDA history contains 3 distinct recall events: 1 open, 2 terminated. Z-0119-2027 (2026-08-28; open, classified): A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may overheat and pose a fire safety risk. [14]
Regulatory snapshot How to read this snapshot
U.S. FDA- 7
- 510(k) clearances
- 0
- De Novo grants
- 0
- PMA approvals
- 0
- Recall events
Latest recorded source review: 2026-10-20.
View 1 documented open recall event
Includes open events outside the mapped current portfolio; those events are excluded from the snapshot count.
Commercial portfolio snapshot
Documented commercial product families.
Planning and navigation
Intellijoint Navigation System ↗
Orthopedic navigation platform used in joint-replacement workflows. [20][23]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Planning and navigation
Intellijoint VIEW ↗
Preoperative orthopedic planning software. [20][24]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Products with unconfirmed commercial availability
Legacy workstation
Specified G2 navigation workstations ↗
Eight workstations identified by serial number in the FDA recall; affected MacBook Pro battery may overheat. [20]
Commercial availability not establishedLegacy affected workstation configuration; current availability not established.
Commercial development
Commercial navigation and planning portfolio. The scoped workstation recall must not be generalized to every device. [20]
26 Cited Sources
Accessed 10/29/2026
26 Cited Sources
Accessed 10/29/2026
[1] FDA 510(k) database — research search ↗FDA / openFDA · regulatory record
[2] FDA K133759 — INTELLIJOINT HIP ↗U.S. Food and Drug Administration · regulatory record
[3] FDA K151364 — Intellijoint HIP(tm) System ↗U.S. Food and Drug Administration · regulatory record
[4] FDA K162364 — Intellijoint HIP Generation 2A System ↗U.S. Food and Drug Administration · regulatory record
[5] FDA K171525 — Intellijoint HIP Generation 2B System ↗U.S. Food and Drug Administration · regulatory record
[6] FDA K172849 — Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray ↗U.S. Food and Drug Administration · regulatory record
[7] FDA K191507 — Intellijoint® Navigation System ↗U.S. Food and Drug Administration · regulatory record
[8] FDA K211876 — Intellijoint VIEW ↗U.S. Food and Drug Administration · regulatory record
[9] FDA De Novo database — research search ↗FDA / openFDA · regulatory record
[10] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record
[11] FDA PMA database — research search ↗FDA / openFDA · regulatory record
[12] FDA recall Z-2228-2019 — Intellijoint Surgical, Inc. ↗U.S. Food and Drug Administration · regulatory record
[13] FDA recall Z-1559-2020 — Intellijoint Surgical, Inc. ↗U.S. Food and Drug Administration · regulatory record
[14] FDA recall Z-0119-2027 — Intellijoint Surgical, Inc. ↗U.S. Food and Drug Administration · regulatory record
[15] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record
[16] FDA UDI database — research search ↗FDA / openFDA · regulatory record
[17] Employer hiring source reviewed ↗Intellijoint Surgical · company website
[18] Active role: Software Development Manager ↗Intellijoint Surgical · company website
[19] Home - Intellijoint Surgical ↗Intellijoint Surgical · company website
[20] Company background and product scope ↗Intellijoint Surgical · company website
[21] Leadership team ↗Intellijoint Surgical · company website
[22] FDA 510(k) K133759 ↗U.S. Food and Drug Administration · regulatory database
[23] FDA 510(k) K191507 ↗U.S. Food and Drug Administration · regulatory database
[24] FDA 510(k) K211876 ↗U.S. Food and Drug Administration · regulatory database
[25] FDA recall Z-0119-2027 ↗U.S. Food and Drug Administration · regulatory database
[26] FedDev Ontario announces C$4.8 million repayable contribution to Intellijoint Surgical ↗FedDev Ontario · company announcement