# Zimmer Medizinsysteme GmbH

- Location (FDA's records): Neu-Elm, DE
- FDA decisions: 13 (2016–2026): 13 510(k) clearances
- Product codes: NGX (6), PBX (2), KPI (1), ITH (1), IMJ (1), IPF (1), GEX (1)
- 510(k) review time since 2016: median 120 days, against 160 for FDA's reviews in the same codes and years (7 of 12 faster)
- Predicates its devices cite: 13 (3 its own); citations of its devices by later devices: 7 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- BTL Industries, Inc.: 4 (https://510kreport.com/company/btl-industries)
- Enraf-Nonius, B.V.: 1 (https://510kreport.com/company/enraf-nonius)
- Bios S.R.L.: 1 (https://510kreport.com/company/bios)
- Chattanooga Group, Inc.: 1 (https://510kreport.com/company/chattanooga-group)
- Winback USA Corp: 1 (https://510kreport.com/company/winback-usa)
- Zimmer Elektromedizin GmbH: 1 (https://510kreport.com/company/zimmer-elektromedizin)
- Johari Digital Healthcare, Ltd.: 1 (https://510kreport.com/company/johari-digital-healthcare)

## Firms that cite its devices most
- BTL Industries, Inc.: 2 (https://510kreport.com/company/btl-industries)
- Beijing Sano Laser S&T Development Co.,Ltd: 1 (https://510kreport.com/company/beijing-sano-laser-s-t-development)
- Beijing Nubway S&T Co., Ltd.: 1 (https://510kreport.com/company/beijing-nubway-s-t)

## Its most-cited devices
- K220020: Cryo 7 (2022), cited by 2
- K161862: ThermoPro (2016), cited by 1
- K220601: CoolTone (2022), cited by 1
- K203488: emField (2021), cited by 1
- K192940: CoolTone (2019), cited by 1
- K182963: emFieldPro (2019), cited by 1

## Recent decisions
- K253408: CoolTone (Jan 16, 2026)
- K251378: CoolTone (Jul 14, 2025)
- K240347: PTG-05 (Jul 21, 2024)
- K240178: RFG-01 (Jul 15, 2024)
- K230780: MFG-05 (Oct 5, 2023)
- K213256: ThermoTK (May 25, 2023)
- K222912: c1Trac (May 16, 2023)
- K220601: CoolTone (Apr 1, 2022)

Source page: https://510kreport.com/company/zimmer-medizinsysteme