510(k) · Cleared
ClearedBiomet Headless Compression and Twist-Off Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · HWC Screw, Fixation, Bone
Cleared on Feb 7, 2019 as substantially equivalent to K142658 (Biomet Manufacturing Corp, 2014) after a 30-day review. Its family tree reaches back 4 generations to 1979. 4 later devices descend from it.
- Decided
- Feb 7, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K792022 (1979). 14 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 3 generations backK962236 Scarf Thread-Head ScrewLandos, Inc. · 1996
- 2 generations backK062352 FRS ScrewDePuy Orthopaedics, Inc. · 2006
- 1 generation backK142658 Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp · 2014 · Recalled
- This deviceK190035 Biomet Headless Compression and Twist-Off ScrewsBiomet, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK193214 WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated…Biomet, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK211290 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
- Descendant · 3 generations on · 0 of its ownK242691 OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies · 2024
- Descendant · 3 generations on · 0 of its ownK230226 Integrity-SI® Fusion SystemOsteoCentric Technologies · 2023
Most influential descendants
Showing 4 of 4 · See all- K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc. · 2020 · cites it directly3descendants
- K211290Cannulated Fasteners and NutsOsteoCentric Technologies · 2021 · 2 generations on2descendants
- K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies · 2024 · 3 generations on0descendants
- K230226Integrity-SI® Fusion SystemOsteoCentric Technologies · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −3 | K962236 | Scarf Thread-Head Screw | Landos, Inc. | 1996 | — |
| −2 | K062352 | FRS Screw | DePuy Orthopaedics, Inc. | 2006 | — |
| −1 | K142658 | Biomet Headless Compression and Twist-off Screws | Biomet Manufacturing Corp | 2014 | 2 |
| 0 (this device) | K190035 | Biomet Headless Compression and Twist-Off Screws | Biomet, Inc. | 2019 | — |
| +1 | K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw… | Biomet, Inc. | 2020 | — |
| +2 | K211290 | Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2021 | — |
| +3 | K242691 | OsteoCentric Technologies Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2024 | — |
| +3 | K230226 | Integrity-SI® Fusion System | OsteoCentric Technologies | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 22.3 · 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 |
|---|---|---|---|
| * | K142658 | Biomet Headless Compression and Twist-off ScrewsSummary page 4… HWC– Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) Predicate Device(s): K142658 Headless Compression and Twist-Off Screws Biomet Inc. Purpose and Device Description: The Biomet Headless C… | 2014 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System… | 2020 | 3 |
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 40 years and passes through 5 companies; a new generation was cleared every 10.1 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K193214 (Biomet, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K142658.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.
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/K190035 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190035: Biomet Headless Compression and Twist-Off Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190035
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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