Identifiers
- 510(k) Number
- K202768 FDA 510(k)
- FDA Product Code
- LZO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3353 FDA 510(k)
- Regulation Number
- 888.3353 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The KOSMO Femoral Stem is a femoral component for total hip arthroplasty, designed as a modular implant for use in primary or revision hip replacement procedures. It is classified under product code LZO and is intended for orthopedic applications, featuring a bone-compacting design to enhance fixation within the femoral canal. This device is part of an artificial hip replacement system, providing structural support and restoring joint function in patients with degenerative or damaged hip joints.
The KOSMO Femoral Stem is supplied sterile and intended for single-use in a surgical setting. It is manufactured by B-One Ortho, Corp. and has received FDA clearance under the Traditional 510(k) pathway (K202768), following a review by the Orthopedic (OR) Advisory Committee. The device is not MRI-safe, and storage conditions must adhere to sterile packaging guidelines. No additional regulatory approvals beyond the stated 510(k) clearance are referenced in the available data.
Frequently asked questions
What is the KOSMO Femoral Stem used for?
The KOSMO Femoral Stem is designed as a modular implant for total hip arthroplasty, intended for both primary and revision hip replacement procedures. Its bone-compacting design improves fixation within the femoral canal, providing structural support and restoring joint function in patients with degenerative or damaged hip joints.
Is the KOSMO Femoral Stem supplied sterile and for single-use?
Yes, the KOSMO Femoral Stem is supplied sterile and intended exclusively for single-use in surgical settings. This ensures patient safety and compliance with sterile procedure protocols.
How is the KOSMO Femoral Stem stored?
The device must be stored according to sterile packaging guidelines to maintain its sterility. Improper storage could compromise its integrity and safety for surgical use.
Is the KOSMO Femoral Stem MRI-safe?
No, the KOSMO Femoral Stem is not MRI-safe. Patients with this implant should avoid MRI procedures, as the device may interfere with imaging or pose safety risks.
What regulatory pathway was followed for the KOSMO Femoral Stem?
The KOSMO Femoral Stem received FDA clearance under the Traditional 510(k) pathway (K202768), following review by the Orthopedic (OR) Advisory Committee. The device was determined to be substantially equivalent to a predicate product.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: KOSMO Femoral Stem (K202768) — FDA 510 (k) | Innolitics, K202768 FDA 510 (k) - KOSMO Femoral Stem | B-One Ortho, Corp., B-One Ortho, Corp. FDA 510(k) Orthopedic Products - Latest 2026
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202768 | Class II | Active |
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Manufacturer
- Manufacturer
- B-One Ortho, Corp.
Sources (1)
- FDA 510(k) K202768 24 fields · synced Oct 1, 2026