Chronos Tricalcium Prosphate (Chronos TCP)
FDA 510(k) K013072 · Synthes
510(k) numberK013072
Submission
- Device name
- Chronos Tricalcium Prosphate (Chronos TCP)
- Applicant
- Synthes
Paoli, PA, US - Received
- September 13, 2001
- Decision date
- November 26, 2002
- 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
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 |
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| 510(k) | Device | Decision |
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| K254093 | DePuy Synthes VOLT Medial Distal Femur 3.5 Plating SystemHRS · Traditional | 03/10/2026SE |
| K260069 | DePuy Synthes VOLT Proximal Tibia 3.5 Plating SystemHRS · Traditional | 03/09/2026SE |
| K254054 | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating SystemHRS · Traditional | 03/02/2026SE |
| K243715 | Synthes Patient Specific ImplantsGXN · Traditional | 11/12/2025SE |
| K241927 | Synthes Graphic Case & Tray SystemKCT · Traditional | 03/28/2025SE |
| K233994 | VOLT Proximal Humerus 3.5 Plating SystemHRS · Traditional | 07/26/2024SE |
| K233967 | DePuy Synthes MatrixSTERNUM Fixation SystemHRS · Traditional | 05/09/2024SE |
| K131792 | Synthecel Dura Repair, Synthecel Dura OnlayGXQ · Traditional | 12/16/2013SE |
| K123723 | Synthes Matrixneuro Cranial Plating SystemGWO · Traditional | 09/05/2013SE |
| K122455 | Synthes Small External Fixation System, Synthes Large External Fixation SystemKTT · Traditional | 04/11/2013SE |
Questions and answers
When was Chronos Tricalcium Prosphate (Chronos TCP) cleared by the FDA?
Chronos Tricalcium Prosphate (Chronos TCP) (K013072) received a 510(k) decision of Substantially Equivalent on November 26, 2002, 439 days after the submission was received.
What is the product code of K013072?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.