510(k) · Cleared
ClearedKLS Martin Cannulated Headless Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS Martin L.P. · HWC Screw, Fixation, Bone
Cleared on Dec 19, 2016 as substantially equivalent to K112737 (Trilliant Surgical, Ltd., 2011) and 1 other predicate after a 229-day review. Its family tree reaches back 2 generations to 2002. 2 later devices descend from it.
- Decided
- Dec 19, 2016
- Review
- 229 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K021556 (2002). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK021556 Synthes 2.4 MM Cannulated Compression ScrewSynthes (Usa) · 2002
- 1 generation backK112737 Tiger Headless Cannulated ScrewsTrilliant Surgical, Ltd. · 2011 · Recalled
- This deviceK161259 KLS Martin Cannulated Headless ScrewsKLS Martin L.P. · 2016
- Descendant · cites it directly · 1 of its ownK241018 KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P. · 2024
- Descendant · 2 generations on · 0 of its ownK250988 KLS Martin Pure Pectus SystemKLS-Martin L.P. · 2025
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 |
|---|---|---|---|---|---|
| −2 | K021556 | Synthes 2.4 MM Cannulated Compression Screw | Synthes (Usa) | 2002 | — |
| −1 | K112737 | Tiger Headless Cannulated Screws | Trilliant Surgical, Ltd. | 2011 | 4 |
| 0 (this device) | K161259 | KLS Martin Cannulated Headless Screws | KLS Martin L.P. | 2016 | — |
| +1 | K241018 | KLS Martin Orthopedic Implants - MR Conditional | KLS-Martin L.P. | 2024 | — |
| +2 | K250988 | KLS Martin Pure Pectus System | KLS-Martin L.P. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K112737 | Tiger Headless Cannulated ScrewsSummary page 4…allic bone fixation fastener Class II, 21 CFR 888.3040, Product Code HWC Predicates: Tiger Headless Cannulated Screws (K112737) (Primary) Synthes 3.0 mm Headless Compression Screws (K050636) Device Description: The KLS Mart… | 2011 |
| * | K050636 | Synthes 3.0MM Headless Compression ScrewsSummary page 4…Code HWC Predicates: Tiger Headless Cannulated Screws (K112737) (Primary) Synthes 3.0 mm Headless Compression Screws (K050636) Device Description: The KLS Martin Cannulated Headless Screws (CHS) system is comprised of headless cannulated screws intended… | 2005 |
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 |
|---|---|---|---|
| K241018 | KLS Martin Orthopedic Implants - MR Conditional | 2024 | 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K241018 (KLS-Martin L.P., 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K112737.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
KLS Martin Cannulated Headless Screws are intended for the treatment of fractures, osteotomies, arthrodeses, and non-unions of small bones in the hand, wrist, foot, and ankle.
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/K161259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161259: KLS Martin Cannulated Headless Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161259
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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