510(k) · Cleared
ClearedTwinfix Interfragmentary Compression Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Leibinger · HRS Plate, Fixation, Bone
Cleared on Jan 8, 2002 as substantially equivalent to K961498 (Howmedica, Inc., 1997) after a 56-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Jan 8, 2002
- Review
- 56 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961498 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK961498 Resch Arthroscopic and Percutaneous Screw Fixation System (a.S.F.)Howmedica, Inc. · 1997
- This deviceK013775 Twinfix Interfragmentary Compression Screw SystemStryker Leibinger · 2002
- Descendant · cites it directly · 1 of its ownK063244 Arc Surgical Bone Reduction ScrewArc Surgical, LLC · 2006
- Descendant · 2 generations on · 0 of its ownK111608 Slic Screw Repair SystemAcumed, LLC · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961498 | Resch Arthroscopic and Percutaneous Screw Fixation System (a.S.F.) | Howmedica, Inc. | 1997 | — |
| 0 (this device) | K013775 | Twinfix Interfragmentary Compression Screw System | Stryker Leibinger | 2002 | — |
| +1 | K063244 | Arc Surgical Bone Reduction Screw | Arc Surgical, LLC | 2006 | — |
| +2 | K111608 | Slic Screw Repair System | Acumed, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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 |
|---|---|---|---|
| * | K961498 | Resch Arthroscopic and Percutaneous Screw Fixation System (a.S.F.)Summary page 2…percutaneous screw placement using K-wire as a guide to minimize the incision. Substantial Equivalence The TwinFix® Interfragmentary Compression Screw is (dentical to K961498, Resch Arthroscopic and Percutaneous Screw Fixation System in all respects of fixation applications of small bones. A table of &… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063244 | Arc Surgical Bone Reduction Screw | 2006 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K063244 (Arc Surgical, LLC, 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Stryker Leibinger, TwinFix® Interfragmentary Compression Screw System is intended to be used for fractures or arthrodesis of carpals and metacarpals, radial head and radial styloid fractures, metatarsal fractures and osteotomies of the forefoot and intra-articular arthrodesis in the wrist.
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/K013775 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013775: Twinfix Interfragmentary Compression Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013775
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026