510(k) · Cleared
ClearedUltra™ Compression Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pace Surgical · HWC Screw, Fixation, Bone
Cleared on Nov 6, 2025 as substantially equivalent to K203011 (Paragon 28, Inc., 2020) after a 169-day review. Its family tree reaches back 15 generations to 1996. 1 later device descends from it.
- Decided
- Nov 6, 2025
- Review
- 169 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K962616 (1996). 128 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations between
- 3 generations backK153378 Monster BITE Screw SystemParagon 28 · 2015
- 2 generations backK190586 Monster® Screw SystemParagon 28, Inc. · 2019
- 1 generation backK203011 Monster Screw SystemParagon 28, Inc. · 2020
- This deviceK251555 Ultra™ Compression Screw SystemPace Surgical · 2025
- Descendant · cites it directly · 0 of its ownK261647 Tempo Plating System; Ultra Compression Screw SystemPace Surgical · 2026
Show all 15 generations
- Root · 15 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 14 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 13 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 12 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 11 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 9 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 8 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 7 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 6 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 5 generations backK124027 Monster Screw SystemApogee Orthosolutions · 2013
- 4 generations backK151418 Monster Screw SystemParagon 28 · 2015
- 3 generations backK153378 Monster BITE Screw SystemParagon 28 · 2015
- 2 generations backK190586 Monster® Screw SystemParagon 28, Inc. · 2019
- 1 generation backK203011 Monster Screw SystemParagon 28, Inc. · 2020
- This deviceK251555 Ultra™ Compression Screw SystemPace Surgical · 2025
Most influential descendants
Showing 1 of 1 · See all- K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −14 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −13 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −12 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −11 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −9 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −8 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −7 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −6 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| −5 | K124027 | Monster Screw System | Apogee Orthosolutions | 2013 | — |
| −4 | K151418 | Monster Screw System | Paragon 28 | 2015 | — |
| −3 | K153378 | Monster BITE Screw System | Paragon 28 | 2015 | — |
| −2 | K190586 | Monster® Screw System | Paragon 28, Inc. | 2019 | — |
| −1 | K203011 | Monster Screw System | Paragon 28, Inc. | 2020 | — |
| 0 (this device) | K251555 | Ultra™ Compression Screw System | Pace Surgical | 2025 | — |
| +1 | K261647 | Tempo Plating System; Ultra Compression Screw System | Pace Surgical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 6 | 0 |
| 1996 | 11 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 10 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HWC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K203011 | Monster Screw SystemSummary page 6…3040 Product Code(s) HWC, HTN I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K203011 Monster Screw System HWC Device Description Summary 21 CFR 807.92(a)(4) The Ultra Compression Screw System is intended for the i… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261647 | Tempo Plating System; Ultra Compression Screw System | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 28 of the 128 ancestors have a recall of any class.
- Of its descendants, K261647 (Pace Surgical, 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K203011.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
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 -…
Read the full statement (182 words)
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251555 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251555: Ultra™ Compression Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251555
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026