510(k) · Cleared
ClearedSynthes 3.0 MM PC-Fix System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HWC Screw, Fixation, Bone
Cleared on May 11, 1998 after a 25-day review. The FDA summary names its predicate without a number. 1 of the 711 devices in its family, counting itself, has a Class I recall. 710 later devices descend from it.
- Decided
- May 11, 1998
- Review
- 25 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
710 later devices descend from it, 1 citing it directly. 1 of the 711 devices in this family, counting this one, has a Class I recall.
- This deviceK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- Descendant · cites it directly · 709 of its ownK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- Descendant · 2 generations on · 690 of its ownK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 584 of its ownK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- Descendant · 3 generations on · 501 of its ownK062216 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 495 of its ownK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
Showing 5 of 710 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 710 · See all- K991407Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999 · cites it directly709descendants
- K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Smith & Nephew, Inc. · 2003 · 2 generations on690descendants
- K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc. · 2005 · 3 generations on584descendants
- K062216Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2006 · 3 generations on501descendants
- K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007 · 3 generations on495descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| +1 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| +2 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| +3 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| +3 | K062216 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2006 | 1 |
| +3 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 9 | 0 |
| 2010 | 11 | 0 |
| 2011 | 15 | 0 |
| 2012 | 20 | 0 |
| 2013 | 29 | 0 |
| 2014 | 36 | 0 |
| 2015 | 41 | 0 |
| 2016 | 30 | 0 |
| 2017 | 51 | 0 |
| 2018 | 31 | 0 |
| 2019 | 37 | 0 |
| 2020 | 41 | 0 |
| 2021 | 47 | 1 |
| 2022 | 41 | 0 |
| 2023 | 51 | 0 |
| 2024 | 66 | 0 |
| 2025 | 60 | 0 |
| 2026 | 73 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | — | Synthes PC-Fix Named without a submission number |
What descends from it? (710)
See all 7101 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991407 | Synthes Locking Calcaneal Plates | 1999 | 709 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K991407 (Synthes (Usa), 1999) has gone furthest, with 709 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 Synthes 3.0 mm PC-Fix™ is a long bone and small bone plate and screw system, intended to treat fractures of various bones, including the radius, ulna, distal tibia, pelvis, clavicle, fibula, humerus, and scapula.
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/K981372 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981372: Synthes 3.0 MM PC-Fix System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981372
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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