# Pace Surgical

- Location (FDA's records): Malvern, PA
- FDA decisions: 3 (2025–2026): 3 510(k) clearances
- Product codes: HRS (2), HWC (1)
- 510(k) review time since 2016: median 107 days, against 82 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 1 (1 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
- Paragon 28, Inc.: 3 (https://510kreport.com/company/paragon-28)

## Its most-cited devices
- K251555: Ultra™ Compression Screw System (2025), cited by 1

## Recent decisions
- K263407: Tempo Plating System (Oct 23, 2026)
- K261647: Tempo Plating System; Ultra Compression Screw System (Sep 3, 2026)
- K251555: Ultra™ Compression Screw System (Nov 6, 2025)

Source page: https://510kreport.com/company/pace-surgical