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Sign in to claim this brandBiomet Sports Medicine
US
Last updated May 23, 2026
What Biomet Sports Medicine makes
Biomet Sports Medicine manufactures orthopaedic fixation devices, including bioabsorbable and non-bioabsorbable bone screws, ligament and tendon anchors, and patellofemoral joint prostheses. Their portfolio also covers orthopaedic bone pins, tibial inserts, and specialized fixation systems for ligament and tendon repairs, such as the REUNITE SCREW SYSTEM and TOGGLELOC WITH ZIPLOOP.
Their devices are regulated under FDA Class I and Class II classifications, with authorisations recorded via 510(k) clearances and the Unique Device Identifier (UDI) system. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Biomet Sports Medicine manufacture?
Biomet Sports Medicine specializes in orthopaedic fixation devices. Their portfolio includes bioabsorbable and non-bioabsorbable bone screws, ligament and tendon anchors (both bioabsorbable and non-bioabsorbable), patellofemoral joint prostheses, orthopaedic bone pins, tibial inserts, and specialized systems like the REUNITE SCREW SYSTEM and TOGGLELOC WITH ZIPLOOP. These devices are designed for ligament and tendon repairs, bone stabilization, and joint reconstruction.
Where is Biomet Sports Medicine based?
Biomet Sports Medicine is headquartered in the United States. The company’s focus on orthopaedic devices aligns with the regulatory framework of the FDA, which oversees medical devices in the country.
Which regulatory registries or databases list Biomet Sports Medicine’s devices?
Biomet Sports Medicine’s devices are recorded in the FDA’s 510(k) clearance database and the Unique Device Identifier (UDI) system. These registries track the authorization status of Class I and Class II devices, ensuring transparency in their regulatory pathway.
How are Biomet Sports Medicine’s devices classified under FDA regulations?
Biomet Sports Medicine’s devices fall under FDA Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The specific classification depends on the device’s intended use and potential risk to patients.
What is the reasoning behind the FDA’s classification of Biomet Sports Medicine’s devices?
The FDA categorizes devices based on their risk level and intended use. For example, bioabsorbable bone screws (like the LACTONAIL) and tendon anchors (like TOGGLELOC WITH ZIPLOOP) are often classified as Class II because they involve moderate surgical procedures where performance and safety are critical. In contrast, simpler devices like certain bone pins may qualify as Class I due to lower inherent risk. The classification ensures appropriate regulatory oversight tailored to the device’s purpose.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (175)
Page 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Reunite Screw System | 948442 | FDA UDI | Class II | Active |
| Prelude Pf | 110005117 | FDA UDI | Class II | Active |
| Prelude Pf | 110018149 | FDA UDI | Class II | Active |
| Lactonail | 948922 | FDA UDI | Class II | Active |
| Axl Crosspin | 905876 | FDA UDI | Class II | Active |
| Toggleloc With Ziploop | 909874 | FDA UDI | Class II | Active |
| Toggleloc With Ziploop | 909849 | FDA UDI | Class II | Active |
| Prelude Pf | 110018155 | FDA UDI | Class II | Active |
| Prelude Pf | 110005119 | FDA UDI | Class II | Active |
| Mini Bone Mulch | 909325 | FDA UDI | Class II | Active |
| No Profile | 905401 | FDA UDI | Class II | Active |
| Bone Mulch | 907317 | FDA UDI | Class II | Active |
| Lactonail | 948916 | FDA UDI | Class II | Active |
| Prelude Pf | 110004332 | FDA UDI | Class II | Active |
| No-Profile | 904636 | FDA UDI | Class II | Active |
| Reunite Screw System | 948473 | FDA UDI | Class II | Active |
| Arthrorivet | 905800 | FDA UDI | Class II | Active |
| Titanium Interference Screw | 909673 | FDA UDI | Class II | Active |
| Prelude Pf | 110005115 | FDA UDI | Class II | Active |
| Prelude Pf | 110018153 | FDA UDI | Class II | Active |
| Ezloc | 904781 | FDA UDI | Class II | Active |
| Poly Suture Button | 904219 | FDA UDI | Class I | Active |
| Axl Crosspin | 907875 | FDA UDI | Class II | Active |
| No-Profile | 904644 | FDA UDI | Class II | Active |
| Prelude Pf | 110005120 | FDA UDI | Class II | Active |
| Bone Mulch | 907325 | FDA UDI | Class II | Active |
| Ezloc | 904779 | FDA UDI | Class II | Active |
| Tunneloc | 906512 | FDA UDI | Class II | Active |
| Reunite Screw System | 948451 | FDA UDI | Class II | Active |
| Axl Crosspin | 905874 | FDA UDI | Class II | Active |
| Poly Suture Button | 904215 | FDA UDI | Class I | Active |
| Centraloc Tibial Fixation | 905673 | FDA UDI | Class II | Active |
| No-Profile | 904545 | FDA UDI | Class II | Active |
| No-Profile | 904535 | FDA UDI | Class II | Active |
| Bone Mulch | 907330 | FDA UDI | Class II | Active |
| Reunite Screw System | 948472 | FDA UDI | Class II | Active |
| Centraloc Tibial Fixation | 905682 | FDA UDI | Class II | Active |
| Prelude Pf | 110018151 | FDA UDI | Class II | Active |
| Ezloc | 904785 | FDA UDI | Class II | Active |
| No-Profile | 904540 | FDA UDI | Class II | Active |
| Lactonail | 948906 | FDA UDI | Class II | Active |
| Lactonail | 948902 | FDA UDI | Class II | Active |
| Ezloc | 904789 | FDA UDI | Class II | Active |
| Titanium Interference Screw | 909694 | FDA UDI | Class II | Active |
| Repicci II Resurfacing Knee System | CP112350 | FDA UDI | Class II | Active |
| Harpoon | 902920 | FDA UDI | Class II | Active |
| No Profile | 905402 | FDA UDI | Class II | Active |
| No-Profile | 904632 | FDA UDI | Class II | Active |
| Micromax L15 | 905456 | FDA UDI | Class II | Active |
| No-Profile | 904640 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Biomet Sports Medicine has three recall records initiated between April 17, 2008, and April 24, 2008, all of which are marked as terminated. The recalls involve manufacturing defects: six sizes of the ToggleLoc Artificial Ligament Fixation Device had a suture pull hole drilled in the incorrect location, and EZLoc Femoral Fixation devices from two lots were distributed with the wrong component size inside the packaging.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 24, 2008 | Z-0582-2012 | — | terminated | Six sizes of ToggleLoc, Artificial Ligament Fixation Device, have been manufactured with the suture pull hole drilled in the wrong location on the device. The ToggleLoc implant is deployed with a suture that pulls the device through the tunnel. The hole being drilled in the wrong location will orient the device to pass through the tunnel with the angled end of the implant first. This may caus |
| Apr 17, 2008 | Z-1782-2008 | — | terminated | This recall was initiated following an investigation which identified that: EZLoc Femoral Fixation devices, from two finished good lots were distributed with the incorrect component size inside the package. As supplied, label indicates product size as EZLoc 7-8mm 904780 L305240. Actual product enclosed may be EZLoc 9-10mm. Alternatively, as supplied, label indicates product size as EZLoc 9-1 |
| Apr 17, 2008 | Z-1783-2008 | — | terminated | This recall was initiated following an investigation which identified that: EZLoc Femoral Fixation devices, from two finished good lots were distributed with the incorrect component size inside the package. As supplied, label indicates product size as EZLoc 7-8mm 904780 L305240. Actual product enclosed may be EZLoc 9-10mm. Alternatively, as supplied, label indicates product size as EZLoc 9-1 |