510(k) · Cleared
Recalled · Class II · 2019Biomet Headless Compression and Twist-off Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · HWC Screw, Fixation, Bone
Cleared on Nov 13, 2014 as substantially equivalent to K062352 (DePuy Orthopaedics, Inc., 2006) and 4 other predicates after a 56-day review. Its family tree reaches back 3 generations to 1979. 36 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 13, 2014
- Review
- 56 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 3 generations to K792022 (1979). 13 ancestors in all. 36 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 2 generations backK962236 Scarf Thread-Head ScrewLandos, Inc. · 1996
- 1 generation backK062352 FRS ScrewDePuy Orthopaedics, Inc. · 2006
- This deviceK142658 Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp · 2014
- Descendant · cites it directly · 21 of its ownK190586 Monster® Screw SystemParagon 28, Inc. · 2019
- Descendant · 2 generations on · 9 of its ownK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- Descendant · 3 generations on · 8 of its ownK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
- Descendant · cites it directly · 8 of its ownK180541 DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC · 2018
- Descendant · 2 generations on · 6 of its ownK203011 Monster Screw SystemParagon 28, Inc. · 2020
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K190586Monster® Screw SystemParagon 28, Inc. · 2019 · cites it directly21descendants
- K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020 · 2 generations on9descendants
- K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH · 2023 · 3 generations on8descendants
- K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC · 2018 · cites it directly8descendants
- K203011Monster Screw SystemParagon 28, Inc. · 2020 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −2 | K962236 | Scarf Thread-Head Screw | Landos, Inc. | 1996 | — |
| −1 | K062352 | FRS Screw | DePuy Orthopaedics, Inc. | 2006 | — |
| 0 (this device) | K142658 | Biomet Headless Compression and Twist-off Screws | Biomet Manufacturing Corp | 2014 | — |
| +1 | K190586 | Monster® Screw System | Paragon 28, Inc. | 2019 | — |
| +2 | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | 2020 | — |
| +3 | K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker… | Stryker GmbH | 2023 | — |
| +1 | K180541 | DePuy Synthes 2.0 mm Quick Insertion Screws | Synthes USA Products, LLC | 2018 | — |
| +2 | K203011 | Monster Screw System | Paragon 28, Inc. | 2020 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 8 | 0 |
| 2024 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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? (5)
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 |
|---|---|---|---|
| * | K062352 | FRS ScrewSummary page 4…nce is claimed: The Biomet Headless Compression and Twist-Off Screws are substantially equivalent to the currently marketed devices: • DEPUY ORTHOPAEDICS, INC-K062352 • DEPUY ORTHOPAEDICS, INC-K971069 • LANDOS, INC-K962233 • WRIGHT MEDICAL TECHNOLOGY, INC- K08232… | 2006 |
| * | K971069 | Twist-Off (TM) ScrewSummary page 4…on and Twist-Off Screws are substantially equivalent to the currently marketed devices: • DEPUY ORTHOPAEDICS, INC-K062352 • DEPUY ORTHOPAEDICS, INC-K971069 • LANDOS, INC-K962233 • WRIGHT MEDICAL TECHNOLOGY, INC- K082320 • MEMOMETAL TECHNOLOGIES- K07003… | 1997 |
| * | K962233 | Twist-Off ScrewSummary page 4…antially equivalent to the currently marketed devices: • DEPUY ORTHOPAEDICS, INC-K062352 • DEPUY ORTHOPAEDICS, INC-K971069 • LANDOS, INC-K962233 • WRIGHT MEDICAL TECHNOLOGY, INC- K082320 • MEMOMETAL TECHNOLOGIES- K070039 Device Description The Biomet… | 1996 |
| * | K082320 | Darco Small ScrewSummary page 4…: • DEPUY ORTHOPAEDICS, INC-K062352 • DEPUY ORTHOPAEDICS, INC-K971069 • LANDOS, INC-K962233 • WRIGHT MEDICAL TECHNOLOGY, INC- K082320 • MEMOMETAL TECHNOLOGIES- K070039 Device Description The Biomet Headless Compression and Twist-Off Screws consist of… | 2008 |
| * | K070039 | Memometal Fixos ScrewsSummary page 4…2 • DEPUY ORTHOPAEDICS, INC-K971069 • LANDOS, INC-K962233 • WRIGHT MEDICAL TECHNOLOGY, INC- K082320 • MEMOMETAL TECHNOLOGIES- K070039 Device Description The Biomet Headless Compression and Twist-Off Screws consist of bone screws of various lengths and diameters.… | 2007 |
What descends from it? (36)
See all 363 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 28, 2019 | Class II | Z-1303-2019 | Under Investigation by firm | There is a potential of fracture, bending or shearing of the driver. |
| Mar 28, 2019 | Class II | Z-1302-2019 | Under Investigation by firm | There is a potential of fracture, bending or shearing of the driver. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 4 companies; a new generation was cleared every 10.1 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K190586 (Paragon 28, Inc., 2019) has gone furthest, with 21 descendants of its own.
- 3 other devices also cite its predicate K062352.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 as stated in the FDA summary.
https://510kreport.com/device/K142658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142658: Biomet Headless Compression and Twist-off Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142658
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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