Mak Oss Femoral Knee Components
FDA 510(k) K131393 · Biomet Orthopedics Corp.
510(k) numberK131393
Submission
- Device name
- Mak Oss Femoral Knee Components
- Applicant
- Biomet Orthopedics Corp.
Warsaw, IN, US - Received
- May 15, 2013
- Decision date
- October 24, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRO – Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3510
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KRO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemKRO · Traditional | Howmedica Osteonics Corp. dba Stryker Orthopaedics | 08/06/2026SE |
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…KRO · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 12/15/2025SE |
| K252303 | Stem Extension Line (USTAR II System)KRO · Special | United Orthopedic Corporation | 08/22/2025SE |
| K251665 | Triathlon® Hinge Knee SystemKRO · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 07/25/2025SE |
| K242871 | ATTUNE Revision Hinge KneeKRO · Traditional | Depuy Ireland UC | 11/21/2024SE |
| K240043 | EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral…KRO · Traditional | Microport Orthopedics, Inc. | 04/01/2024SE |
| K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…KRO · Traditional | Depuy Ireland UC | 03/21/2024SE |
| K230563 | EVOLUTION® Hinge Knee SystemKRO · Traditional | Microport Orthopedics, Inc. | 09/27/2023SE |
| K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®KRO · Traditional | Stryker | 05/19/2023SE |
| K223069 | Modular Rotating Hinge Knee Systems and Compatible ComponentsKRO · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 04/21/2023SE |
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| 510(k) | Device | Decision |
|---|---|---|
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| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesPHX · Traditional | 04/15/2026SE |
| K243761 | A.L.P.S. Small Fragment Plating SystemHRS · Traditional | 02/19/2025SE |
| K223631 | Comprehensive Segmental Revision System(SRS)KWT · Traditional | 07/12/2023SE |
| K200196 | Taperloc® Complete Hip StemsLZO · Traditional | 12/08/2020SE |
| K112905 | Compress(R) Segmental Humeral Replacement SystemMBF · Traditional | 05/24/2012SE |
| K080528 | E-Poly Tibial BearingsJWH · Traditional | 06/17/2008SE |
| K072879 | Innervue Diagnostic Scope SystemHRX · Traditional | 01/14/2008SE |
| K070955 | Acid Etched Lag ScrewsHSB · Traditional | 10/12/2007SE |
| K033355 | Lactoscrew Screw AnchorHWC · Traditional | 06/30/2004SE |
Questions and answers
When was Mak Oss Femoral Knee Components cleared by the FDA?
Mak Oss Femoral Knee Components (K131393) received a 510(k) decision of Substantially Equivalent on October 24, 2013, 162 days after the submission was received.
What is the product code of K131393?
The FDA product code is KRO – Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3510.