510(k) · Cleared
Recalled · Class II · 20203.Omm Biomet Cannulated Screw System
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 Dec 30, 2014 as substantially equivalent to K140891 (Biomet, Inc., 2014) and 4 other predicates after a 55-day review. Its family tree reaches back 5 generations to 1992. 8 later devices descend from it. It has been recalled once.
- Decided
- Dec 30, 2014
- Review
- 55 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 5 generations to K922322 (1992). 29 ancestors in all, the oldest K792022 (1979). 8 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK922322 Alphatec 3.5MM Znnulated Cortical Lag ScrewAlphatec Mfg., Inc. · 1992
- 4 generations backK013534 Self-Countersinking Bone ScrewBiomet Orthopedics, Inc. · 2001
- 3 generations backK024086 Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc. · 2003
- 2 generations backK082874 Biodrive Cannulated Screw SystemBiomet Trauma · 2009
- 1 generation backK140891 Biomet Cannulated Screw SystemBiomet, Inc. · 2014 · Recalled
- This deviceK143188 3.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp · 2014
- Descendant · cites it directly · 3 of its ownK193214 WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated…Biomet, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK180808 Omni Foot Plating SystemExtremity Medical, LLC · 2018
- Descendant · 2 generations on · 2 of its ownK211290 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
- Descendant · 2 generations on · 1 of its ownK212297 Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021
- Descendant · 3 generations on · 0 of its ownK242691 OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc. · 2020 · cites it directly3descendants
- K180808Omni Foot Plating SystemExtremity Medical, LLC · 2018 · cites it directly3descendants
- K211290Cannulated Fasteners and NutsOsteoCentric Technologies · 2021 · 2 generations on2descendants
- K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021 · 2 generations on1descendant
- K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922322 | Alphatec 3.5MM Znnulated Cortical Lag Screw | Alphatec Mfg., Inc. | 1992 | — |
| −4 | K013534 | Self-Countersinking Bone Screw | Biomet Orthopedics, Inc. | 2001 | — |
| −3 | K024086 | Propeller Head Small Cannulated Screw System | Biomet Orthopedics, Inc. | 2003 | — |
| −2 | K082874 | Biodrive Cannulated Screw System | Biomet Trauma | 2009 | — |
| −1 | K140891 | Biomet Cannulated Screw System | Biomet, Inc. | 2014 | 5 |
| 0 (this device) | K143188 | 3.Omm Biomet Cannulated Screw System | Biomet Manufacturing Corp | 2014 | — |
| +1 | K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw… | Biomet, Inc. | 2020 | — |
| +1 | K180808 | Omni Foot Plating System | Extremity Medical, LLC | 2018 | — |
| +2 | K211290 | Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2021 | — |
| +2 | K212297 | Omni Foot and Ankle Plating System | Extremity Medical, LLC | 2021 | — |
| +3 | K242691 | OsteoCentric Technologies Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1996 | 5 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 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 22.2 · 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 |
|---|---|---|---|
| * | K140891 | Biomet Cannulated Screw SystemSummary page 4…on Fastener (21 CFR 888.3040) Legally marketed devices to which substantial equivalence is claimed: Biomet Cannulated Screw System ‐ K140891 BioDrive Cannulated Screw System ‐ K082874 Synthes Sterile 3.0 mm Cannulated Screw and Threaded Washer ‐ K962823 F… | 2014 |
| * | K082874 | Biodrive Cannulated Screw SystemSummary page 4…FR 888.3040) Legally marketed devices to which substantial equivalence is claimed: Biomet Cannulated Screw System ‐ K140891 BioDrive Cannulated Screw System ‐ K082874 Synthes Sterile 3.0 mm Cannulated Screw and Threaded Washer ‐ K962823 FRS Screw – K062352 Wright Compression Screw… | 2009 |
| * | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSummary page 4…claimed: Biomet Cannulated Screw System ‐ K140891 BioDrive Cannulated Screw System ‐ K082874 Synthes Sterile 3.0 mm Cannulated Screw and Threaded Washer ‐ K962823 FRS Screw – K062352 Wright Compression Screws (DartFire) – K082320 Device Description The 3.0mm Biomet Cannulated Scre… | 1996 |
| * | K062352 | FRS ScrewSummary page 4…ulated Screw System ‐ K140891 BioDrive Cannulated Screw System ‐ K082874 Synthes Sterile 3.0 mm Cannulated Screw and Threaded Washer ‐ K962823 FRS Screw – K062352 Wright Compression Screws (DartFire) – K082320 Device Description The 3.0mm Biomet Cannulated Screw System consists of bone… | 2006 |
| * | K082320 | Darco Small ScrewSummary page 4…ed Screw System ‐ K082874 Synthes Sterile 3.0 mm Cannulated Screw and Threaded Washer ‐ K962823 FRS Screw – K062352 Wright Compression Screws (DartFire) – K082320 Device Description The 3.0mm Biomet Cannulated Screw System consists of bone screws of various lengths and are Ti alloy partiall… | 2008 |
What descends from it? (8)
2 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 |
|---|---|---|---|---|
| Nov 25, 2020 | Class II | Z-0616-2021 | Process control | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 5.3 years on median.
- 5 of the 29 ancestors have a recall of any class.
- Of its descendants, K193214 (Biomet, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K140891.
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?
1. Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
2. Arthrodesis of the foot, wrist and elbow.
3. Small and long bone osteotomies.
4. Fracture fixation of small bones, small bone fragments and long bones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143188: 3.Omm Biomet Cannulated Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143188
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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