# Heraeus Medical GmbH

- Location (FDA's records): Wehrheim, DE
- FDA decisions: 13 (2014–2024): 13 510(k) clearances
- Product codes: LOD (9), KWY (2), JWH (1), KWL (1)
- 510(k) review time since 2016: median 109 days, against 111 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 17 (5 its own); citations of its devices by later devices: 7 (5 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Heraeus Kulzer, Inc.: 8 (https://510kreport.com/company/heraeus-kulzer)
- Exactech, Inc.: 1 (https://510kreport.com/company/exactech)
- Tecres S.P.A.: 1 (https://510kreport.com/company/tecres)
- Heraeus Medical GmbH Technology: 1 (https://510kreport.com/company/heraeus-medical-technology)
- Osteoremedies, LLC: 1 (https://510kreport.com/company/osteoremedies)

## Firms that cite its devices most
- Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE: 1 (https://510kreport.com/company/ormed-grup-medikal-turizm-saglik-hizmetleri-sanayi-ve)
- United Orthopedic Corporation: 1 (https://510kreport.com/company/united-orthopedic)

## Its most-cited devices
- K202475: PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G (2020), cited by 2
- K150119: PALACOS R pro (2015), cited by 1
- K222570: COPAL knee moulds (2023), cited by 1
- K191016: COPAL exchange G Hip and Knee Spacers (2019), cited by 1
- K210607: PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro (2021), cited by 1
- K142157: Palacos R+G Pro (2014), cited by 1

## Recent decisions
- K241674: Osteopal® V (Dec 5, 2024)
- K234028: COPAL® exchange G hip spacer; COPAL® G+V (Feb 15, 2024)
- K222570: COPAL knee moulds (Feb 4, 2023)
- K220492: COPAL exchange G hip spacer (Mar 23, 2022)
- K213812: PALACOS MV pro (Feb 2, 2022)
- K210607: PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro (Jul 9, 2021)
- K202475: PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G (Nov 23, 2020)
- K191016: COPAL exchange G Hip and Knee Spacers (Nov 1, 2019)

Source page: https://510kreport.com/company/heraeus-medical