FM-02 Bone Graft Substitute
FDA 510(k) K102545 · Orthovita, Inc.
510(k) numberK102545
Submission
- Device name
- FM-02 Bone Graft Substitute
- Applicant
- Orthovita, Inc.
Malver, PA, US - Received
- September 3, 2010
- Decision date
- October 27, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code MQV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262230 | Mg OSTEOREVIVE;Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 09/11/2026SE |
| 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 |
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…MQV · Special | Stryker Spine | 04/24/2026SE |
| K253524 | Adaptos®Fuse Bone GraftMQV · Traditional | Biomendex OY | 02/17/2026SE |
| K253147 | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft…MQV · Special | Prosidyan, Inc. | 10/22/2025SE |
| 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 |
More from SurGenTec, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K163621 | Vitoss Bioactive (BA) InjectableMQV · Traditional | 05/02/2017SE |
| K161447 | HydroSet XTMQV · Traditional | 10/06/2016SE |
| K153608 | Vitoss BiModal Bone Graft Substitute Foam StripMQV · Special | 02/12/2016SE |
| K153306 | Imbibe NeedleKNW · Special | 12/18/2015SE |
| K140868 | Stryker Kwic NeedleHAW · Traditional | 06/05/2014SE |
| K140414 | Imbibe NeedleLXH · Traditional | 04/01/2014SE |
| K103173 | Vitoss Ba Bimodal Bioactive Bone Graft SubstituteMQV · Special | 02/07/2011SE |
| K101171 | Orthovita PEEK SpacerODP · Traditional | 01/25/2011SE |
| K091618 | VitomatrixLYC · Traditional | 09/27/2010SE |
| K080108 | Cortoss Bone Augmentation MaterialNDN · Traditional | 06/05/2009SE |
Questions and answers
When was FM-02 Bone Graft Substitute cleared by the FDA?
FM-02 Bone Graft Substitute (K102545) received a 510(k) decision of Substantially Equivalent on October 27, 2010, 54 days after the submission was received.
What is the product code of K102545?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.