# S.H.Pitkar Orthotools Pvt., Ltd.

- Location (FDA's records): Pune, IN
- FDA decisions: 5 (2019–2024): 5 510(k) clearances
- Product codes: KTT (3), HRS (1), NKB (1)
- 510(k) review time since 2016: median 200 days, against 110 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 19 (0 its own); citations of its devices by later devices: 2 (0 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
- Synthes (Usa): 7 (https://510kreport.com/company/synthes-usa)
- Solco Biomedical Co., Ltd.: 2 (https://510kreport.com/company/solco-biomedical)
- Smith & Nephew, Inc., Orthopaedic Div.: 2 (https://510kreport.com/company/smith-nephew-orthopaedic-div)
- Orthocare: 1 (https://510kreport.com/company/orthocare)
- Orthofix, Inc.: 1 (https://510kreport.com/company/orthofix)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Synthes Spine: 1 (https://510kreport.com/company/synthes-spine)
- Depuy Spine, Inc.: 1 (https://510kreport.com/company/depuy-spine)

## Firms that cite its devices most
- Sequel Medical, Inc.: 1 (https://510kreport.com/company/sequel-medical)
- Biodynamik, Inc.: 1 (https://510kreport.com/company/biodynamik)

## Its most-cited devices
- K200518: Pitkar External Fixation System - Rail Mechanism (2020), cited by 1
- K190486: Pitkar External Fixation System (2019), cited by 1

## Recent decisions
- K240233: Pitkar Spinal Pedicle Screw System (Sep 9, 2024)
- K200728: Pitkar DeftFix System (Oct 6, 2020)
- K200518: Pitkar External Fixation System - Rail Mechanism (Jul 29, 2020)
- K192619: Pitkar Locked Plating System (Feb 27, 2020)
- K190486: Pitkar External Fixation System (Oct 16, 2019)

Source page: https://510kreport.com/company/shpitkar-orthotools-pvt