510(k) · Cleared

Recalled · Class II · 2013

Omnifit Self Tapping Cancellous Bone Screws

K894124510(k) TraditionalCleared Sep 11, 198991-day reviewClass II21 CFR 888.3040Recalls 4

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 11, 1989 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it. It has been recalled 4 times.

Decided: Sep 11, 1989
Review: 91 days
Class: Class II
Product code: HWC
Recalls: 4
Predicates: 0

18 later devices descend from it, 1 citing it directly.

This deviceK894124 Omnifit Self Tapping Cancellous Bone ScrewsOsteonics Corp. · 1989
Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
Descendant · 2 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
Descendant · 2 generations on · 7 of its ownK182468 Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
Descendant · 2 generations on · 6 of its ownK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
Descendant · 2 generations on · 6 of its ownK193429 Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · Recalled

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2016high 4 (2022) · low 0 (2017)2026

Most influential descendants

Showing 5 of 18 · See all

K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 2 generations on8descendants
K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019 · 2 generations on7descendants
K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022 · 2 generations on6descendants
K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · 2 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K894124	Omnifit Self Tapping Cancellous Bone Screws	Osteonics Corp.	1989	—
+1	K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016	1
+2	K173499	Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads	Stryker Orthopaedics	2018	2
+2	K182468	Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II…	Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics	2019	—
+2	K220731	Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem	Stryker	2022	—
+2	K193429	Exeter V40 Femoral Stem, Exeter X3 RimFit Cup	Howmedica Osteonics Corp.	2020	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2018	1	0
2019	2	0
2020	1	0
2021	1	0
2022	4	0
2023	1	0
2024	2	0
2025	4	0
2026	1	0

FIG. 1 — Lineage of K894124, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

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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? (18)

See all 18

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

Number	Device	Applicant	Decided	Descendants
K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016	17

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 1, 2013	Class II	Z-0483-2014	Labeling mix-ups	Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm.
Aug 17, 2012	Class II	Z-0387-2013	Mixed-up of materials/components	Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may…
Aug 17, 2012	Class II	Z-0388-2013	Mixed-up of materials/components	Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may…
Dec 20, 2005	Not classified	Z-2007-2008	Labeling mix-ups	The 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.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K153345 (Stryker Orthopaedics, 2016) has gone furthest, with 17 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

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

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

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

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	—

https://510kreport.com/device/K894124 · printed Nov 6, 2026

Cite this page

510(k) Report. “K894124: Omnifit Self Tapping Cancellous Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K894124

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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