510(k) · Cleared
ClearedDepuy Motech Peak Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · HWC Screw, Fixation, Bone
Cleared on Nov 14, 1996 after an 80-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Nov 14, 1996
- Review
- 80 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK963350 Depuy Motech Peak Fixation SystemDepuy, Inc. · 1996
- Descendant · cites it directly · 9 of its ownK190895 MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System…Medos International SARL · 2019
- Descendant · 2 generations on · 3 of its ownK200936 Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- Descendant · 2 generations on · 3 of its ownK192014 SYPMHONY™ OCT SystemMedos International SARL · 2020
- Descendant · 2 generations on · 2 of its ownK192646 SYMPHONY™ OCT SystemMedos International SARL · 2020
- Descendant · 3 generations on · 1 of its ownK252597 Valence Robotic Navigation System; Valence Robotic Navigation…Alphatec Spine, Inc. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K190895MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT…Medos International SARL · 2019 · cites it directly9descendants
- K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 2 generations on3descendants
- K192014SYPMHONY™ OCT SystemMedos International SARL · 2020 · 2 generations on3descendants
- K192646SYMPHONY™ OCT SystemMedos International SARL · 2020 · 2 generations on2descendants
- K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc. · 2026 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963350 | Depuy Motech Peak Fixation System | Depuy, Inc. | 1996 | — |
| +1 | K190895 | MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY… | Medos International SARL | 2019 | — |
| +2 | K200936 | Invictus™ CT Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| +2 | K192014 | SYPMHONY™ OCT System | Medos International SARL | 2020 | — |
| +2 | K192646 | SYMPHONY™ OCT System | Medos International SARL | 2020 | — |
| +3 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For… | Alphatec Spine, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | — | ACE 100° Tubular Plate Named without a submission number | |
| * | — | Synthes (USA) LC-DCP Plate Set System Named without a submission number | |
| * | — | Synthes (USA) 1/3 Tubular Stainless Steel Plates Named without a submission number |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190895 | MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT… | 2019 | 9 |
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?
- Of its descendants, K190895 (Medos International SARL, 2019) has gone furthest, with 9 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 DePuy Motech PEAK Fixation System is intended for use in treating fractures of small bones such as the metacarpals, ulna, radius, humerus and metatarsals and in treating fractures of the lateral malleolus, olecranon, and intra-articular distal tibia.
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/K963350 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963350: Depuy Motech Peak Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963350
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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