# Conformis, Inc.

- Location (FDA's records): Billerica, MA
- FDA decisions: 60 (2005–2023): 60 510(k) clearances
- Product codes: JWH (40), HSX (8), LPH (4), NPJ (2), MEH (2), MBH (2), OOG (1), KCT (1)
- 510(k) review time since 2016: median 59 days, against 88 for FDA's reviews in the same codes and years (19 of 28 faster)
- Predicates its devices cite: 179 (143 its own); citations of its devices by later devices: 150 (143 its own)
- Recalls linked to its devices: 35 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- DePuy Orthopaedics, Inc.: 6 (https://510kreport.com/company/depuy-orthopaedics)
- Encore Medical L.P.: 4 (https://510kreport.com/company/encore-medical)
- Imaging Therapeutics, Inc.: 3 (https://510kreport.com/company/imaging-therapeutics)
- Smith & Nephew, Inc.: 3 (https://510kreport.com/company/smith-nephew)
- Zimmer, Inc.: 3 (https://510kreport.com/company/zimmer)
- Materialise NV: 2 (https://510kreport.com/company/materialise)
- Howmedica Osteonics Corp.: 2 (https://510kreport.com/company/howmedica-osteonics)
- Link America, Inc.: 1 (https://510kreport.com/company/link-america)

## Firms that cite its devices most
- Restor3D: 3 (https://510kreport.com/company/restor3d)
- Bodycad Laboratories, Inc.: 2 (https://510kreport.com/company/bodycad-laboratories)
- Corentec Co., Ltd.: 1 (https://510kreport.com/company/corentec)
- Pipeline Orthopedics: 1 (https://510kreport.com/company/pipeline-orthopedics)

## Its most-cited devices
- K043570: Unicondylar Knee Repair System / Conformis Ucd (2005), cited by 9
- K094050: Itotal CR Knee Replacement System (2010), cited by 8
- K103117: Itotal Cruciate Retaining (CR) Knee Replacement System (2011), cited by 7
- K053488: Conformis Bicompartmental Knee Repair System (2006), cited by 5
- K122870: Itotal Cruciate Retaining (CR) Knee Replacement System (2013), cited by 5
- K112780: Conformis Itotal Cruciate Retaining (CR) Knee Replacement System (2011), cited by 5

## Recent decisions
- K232426: Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts (Sep 8, 2023)
- K223316: Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System (Jul 21, 2023)
- K230846: iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System (Jul 17, 2023)
- K231233: Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS (May 26, 2023)
- K231178: ACTERA™ hip system (May 23, 2023)
- K230844: Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert (Apr 27, 2023)
- K221104: Actera™ hip system (Aug 4, 2022)
- K221404: Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) (Jul 26, 2022)

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