510(k) Report

510(k) · Cleared

Recalled · 2009

Omnifit Bone Screw

K873251510(k) TraditionalCleared Sep 18, 198732-day reviewClass II21 CFR 888.3040Recalls 29

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Osteonics Corp. · HWC Screw, Fixation, Bone

Cleared on Sep 18, 1987 after a 32-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 29 times.

Decided
Sep 18, 1987
Review
32 days
Class
Class II
Product code
HWC
Recalls
29
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2018: 1 descendant cleared1990200020102020
  1. This deviceK873251 Omnifit Bone ScrewOsteonics Corp. · 1987
  2. Descendant · cites it directly · 0 of its ownK173380 b-ONE® Total Hip SystemB-One Ortho, Corp. · 2018

Most influential descendants

Showing 1 of 1 · See all
  • K173380b-ONE® Total Hip SystemB-One Ortho, Corp. · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K873251Omnifit Bone ScrewOsteonics Corp.1987—
+1K173380b-ONE® Total Hip SystemB-One Ortho, Corp.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K873251, 1987–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 26, 2009Not classifiedZ-2176-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2137-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2123-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2126-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2124-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2117-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2119-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2120-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2140-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2142-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2130-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2134-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2125-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2136-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2121-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2135-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2143-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2139-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2138-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2127-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2129-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2122-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2141-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2128-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2133-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2132-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2131-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Jun 26, 2009Not classifiedZ-2118-2009Nonconforming Material/ComponentRaw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Dec 20, 2005Not classifiedZ-2007-2008Labeling mix-upsThe firm has been made aware that one lot of 6.5 Cancellous Bone Screws 25mm was packaged and labeled as 25 mm in length when it maybe 20 mm in length.

The 5 latest of 29 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K173380 (B-One Ortho, Corp., 2018) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

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https://510kreport.com/device/K873251 · printed Nov 6, 2026

Cite this page

510(k) Report. “K873251: Omnifit Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K873251

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026