Oss Bone Graft System and Oss Rapidset Bone Graft System
FDA 510(k) K041089 · Biomet Manufacturing, Inc.
510(k) numberK041089
Submission
- Device name
- Oss Bone Graft System and Oss Rapidset Bone Graft System
- Applicant
- Biomet Manufacturing, Inc.
Warsaw, IN, US - Received
- April 26, 2004
- Decision date
- August 31, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQV – Filler, Bone Void, Calcium Compound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3045
- Specialty
- Orthopedic
- Implant
- Yes
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| K260364 | Device 300419 StripMQV · Traditional | Geistlich Pharma AG | 06/02/2026SE |
| K252797 | JAZBI Resorbable Bone Void FillerMQV · Traditional | Sdip Innovations Pty, Ltd. | 05/26/2026SE |
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| K253524 | Adaptos®Fuse Bone GraftMQV · Traditional | Biomendex OY | 02/17/2026SE |
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| K251522 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 10/13/2025SE |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)MQV · Traditional | Wright Medical Technology, Inc. (Stryker… | 09/30/2025SE |
| K251556 | Device 300423 GranulesMQV · Traditional | Geistlich Pharma AG | 07/17/2025SE |
| K251720 | OsteoFlo HydroFiberMQV · Special | SurGenTec, LLC | 07/02/2025SE |
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| K193038 | Comprehensive Shoulder SystemMBF · Traditional | 10/28/2020SE |
| K182516 | Comprehensive Nano Stemless ShoulderPKC · Traditional | 04/22/2019SE |
| K181611 | Comprehensive Reverse Shoulder SystemPHX · Traditional | 09/24/2018SE |
| K173411 | Comprehensive Segmental Revision System (SRS)PHX · Traditional | 02/08/2018SE |
| K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…PHX · Traditional | 01/03/2018SE |
| K163651 | ExpressBraid Graft ManipulationGAT · Traditional | 02/17/2017SE |
Questions and answers
When was Oss Bone Graft System and Oss Rapidset Bone Graft System cleared by the FDA?
Oss Bone Graft System and Oss Rapidset Bone Graft System (K041089) received a 510(k) decision of Substantially Equivalent on August 31, 2004, 127 days after the submission was received.
What is the product code of K041089?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.