# K251555: Ultra™ Compression Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Pace Surgical
- Decided: Nov 6, 2025 after 169 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K962616 (1996). 128 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203011: Monster Screw System, Paragon 28, Inc. (2020) Summary page 6.

## Most influential descendants
- K261647: Tempo Plating System; Ultra Compression Screw System (2026), 0 descendants of its own

## Indications for use
The Pace Surgical UltraTM Compression Screw System is intended for the internal fixation and stabilization of arthrodeses, osteotomies, fractures, and nonunions of the foot and ankle. The System is specifically indicated for: Fractures and Osteotomies - Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc) - Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture) - Talar fractures - Ankle fractures - Navicular fractures - Fractures of the fibula, malleolus, and calcaneus - Metatarsal and phalangeal osteotomies - Weil osteotomy - Calcaneal osteotomy Fusion resulting from neuropathic osteoarthopathy (Charcot), example: - Medial and lateral column - Subtalar, talonavicular, and calcaneocuboid Arthrodesis and Deformity Correction - 1st MTP arthrodesis - Metatarsal deformity correction - Tarsometatarsal joint arthrodesis - Naviculocuneiform joint arthrodesis - Talonavicular arthrodesis - Subtalar joint arthrodesis - Triple arthrodesis - Medial column arthrodesis - Subtalar joint distraction arthrodesis - Ankle arthrodesis - Lateralizing calcaneal osteotomy - Lateral column lengthening - Hammertoe Hallux Valgus Correction - Fixation of osteotomies (i.e. Akin, Scarf, Chevron) - Interphalangeal (IP) arthrodesis - Proximal, midshaft, or distal osteotomy - Lapidus arthrodesis

Source page: https://510kreport.com/device/K251555
Methodology: https://510kreport.com/methodology