# Osteogenics, Inc.

- Location (FDA's records): Burlington, WI
- FDA decisions: 6 (1996–2007): 6 510(k) clearances
- Names in FDA's records: Osteogenics, Inc. (4); Osteogenics Co. (2)
- Product codes: FTL (2), LYC (2), GXP (2)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 15 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- W. L. Gore & Associates, Inc.: 2 (https://510kreport.com/company/w-l-gore-associates)
- Dentsply Intl.: 2 (https://510kreport.com/company/dentsply-intl)
- American Custom Medical, Inc.: 1 (https://510kreport.com/company/american-custom-medical)
- Imtec Corp.: 1 (https://510kreport.com/company/imtec)

## Firms that cite its devices most
- Unicare Biomedical, Inc.: 2 (https://510kreport.com/company/unicare-biomedical)
- Stryker Instruments: 2 (https://510kreport.com/company/stryker-instruments)
- Norian Corp.: 2 (https://510kreport.com/company/norian)
- Stryker Leibinger GmbH & Co KG: 2 (https://510kreport.com/company/stryker-leibinger)
- Neoss, Ltd.: 1 (https://510kreport.com/company/neoss)
- Osteogenics Biomedical, Inc.: 1 (https://510kreport.com/company/osteogenics-biomedical)
- Aperta, LLC: 1 (https://510kreport.com/company/aperta)
- Kinetic Concepts, Inc.: 1 (https://510kreport.com/company/kinetic-concepts)

## Its most-cited devices
- K972278: Cytoplast Regentex Titanium 250 (1997), cited by 4
- K953339: Bonesource Hydroxyapatite Cement (Hac) (1996), cited by 4
- K964537: Bonesource Hydroxyapatite Cement (Hac) (1997), cited by 3
- K983753: Star Temporary Wound Cover (1999), cited by 2
- K964342: Cytoplast GBR (1997), cited by 2

## Recent decisions
- K061934: XTAC (Jul 17, 2007)
- K983753: Star Temporary Wound Cover (Nov 18, 1999)
- K972278: Cytoplast Regentex Titanium 250 (Aug 6, 1997)
- K964342: Cytoplast GBR (Mar 11, 1997)
- K964537: Bonesource Hydroxyapatite Cement (Hac) (Jan 24, 1997)
- K953339: Bonesource Hydroxyapatite Cement (Hac) (Jun 27, 1996)

Source page: https://510kreport.com/company/osteogenics