# Pega Medical, Inc.

- Location (FDA's records): Laval, CA
- FDA decisions: 12 (2003–2022): 12 510(k) clearances
- Product codes: HSB (7), HRS (2), KTT (1), HWC (1), OBT (1)
- 510(k) review time since 2016: median 184 days, against 122 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 33 (11 its own); citations of its devices by later devices: 20 (11 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 6 (https://510kreport.com/company/synthes-usa)
- OrthoPediatrics Corp.: 3 (https://510kreport.com/company/orthopediatrics)
- Fxdevices: 2 (https://510kreport.com/company/fxdevices)
- Zimmer, Inc.: 2 (https://510kreport.com/company/zimmer)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Osteonics Corp.: 1 (https://510kreport.com/company/osteonics)
- Howmedica Osteonics Corp.: 1 (https://510kreport.com/company/howmedica-osteonics)
- Biomet, Inc.: 1 (https://510kreport.com/company/biomet)

## Firms that cite its devices most
- Orthopediatrics Canada Ulc Dba Pega Medical: 4 (https://510kreport.com/company/orthopediatrics-canada-ulc-dba-pega-medical)
- OrthoPediatrics Corp.: 2 (https://510kreport.com/company/orthopediatrics)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- Orthofix, Inc.: 1 (https://510kreport.com/company/orthofix)
- Citieffe S.R.L.: 1 (https://510kreport.com/company/citieffe)

## Its most-cited devices
- K041393: Fassier-Duval Telscopic IM System (2004), cited by 5
- K020885: Fassire-Duval Telescopic IM System (2003), cited by 5
- K192710: The Simple Locking Intramedullary (Slim) System (2020), cited by 3
- K160545: Gap Endo-Exo Medullary System (2016), cited by 2
- K211292: Fassier-Duval Telescopic IM System (2021), cited by 2
- K143355: The Simple Locking IntraMedullary (SLIM) System (2015), cited by 1

## Recent decisions
- K220190: The GIRO Growth Modulation System (Oct 24, 2022)
- K211292: Fassier-Duval Telescopic IM System (May 26, 2021)
- K192710: The Simple Locking Intramedullary (Slim) System (Jun 24, 2020)
- K170704: The Locking Pediatric Osteotomy Plate (LolliPOP) System (Sep 8, 2017)
- K163003: Y3 Proximal Femoral Plate System (Mar 16, 2017)
- K160545: Gap Endo-Exo Medullary System (Nov 23, 2016)
- K143355: The Simple Locking IntraMedullary (SLIM) System (Jul 10, 2015)
- K131591: Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe) (Nov 27, 2013)

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