510(k) · Cleared

Cleared

Osteonics N2/Vac Packaging Process

K955944510(k) TraditionalCleared Apr 9, 1996133-day reviewClass II21 CFR 888.3660

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

Osteonics Corp. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Cleared on Apr 9, 1996 as substantially equivalent to K934060 (Howmedica Corp., 1995) and 2 other predicates after a 133-day review. Its family tree reaches back 1 generation to 1995.

Decided: Apr 9, 1996
Review: 133 days
Class: Class II
Product code: KWS
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K934060 (1995). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK934060 Howmedica (R) Acetabular Comp Pack/Manuf Meth ChangeHowmedica Corp. · 1995
This deviceK955944 Osteonics N2/Vac Packaging ProcessOsteonics Corp. · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K934060	Howmedica (R) Acetabular Comp Pack/Manuf Meth Change	Howmedica Corp.	1995	—
0 (this device)	K955944	Osteonics N2/Vac Packaging Process	Osteonics Corp.	1996	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	2	0

FIG. 1 — Lineage of K955944, 1995–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 KWS? 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 KWS device

#1 K220847 AETOS Shoulder Systemscore 21.1 · 16 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? (3)

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	Applicant	Decided	Recalls
*	K934060	Howmedica (R) Acetabular Comp Pack/Manuf Meth Change Summary page 1 …under the various, other packaging methods recently put forth by other orthopedic implant manufacturers. The following predicate 510(k)s are identified for comparison: K934060: Howmedica Acetabular Components Packaging and Manufacturing Methods Change K936292: Howmedica Knee Components Packaging and Ma…	Howmedica Corp.	1995	—
*	K936292	Packaging and Manufacturing Methods Change/Knee Components Summary page 1 …lant manufacturers. The following predicate 510(k)s are identified for comparison: K934060: Howmedica Acetabular Components Packaging and Manufacturing Methods Change K936292: Howmedica Knee Components Packaging and Manufacturing Methods Change K940743: DePuy Vacuum Nitrogen (N,) Flush - Barrier Packagi…	Howmedica Corp.	1995	—
*	K940743	Uhmwpe Components-Change in Packaging Summary page 1 …son: K934060: Howmedica Acetabular Components Packaging and Manufacturing Methods Change K936292: Howmedica Knee Components Packaging and Manufacturing Methods Change K940743: DePuy Vacuum Nitrogen (N,) Flush - Barrier Packaging Page 1 Change in Packaging for Osteonics’ UHMWPE Component…	Depuy, Inc.	1995	—

Also cleared against K934060: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

None of the 3 ancestors has a recall.
3 other devices also cite its predicate K934060.

How does its category compare?

All KWS devices

KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWS

3in 2025

2007high 12 (2013) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWS

97in 2025

2007high 250 (2023) · low 33 (2010)2026

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

Recalls per year · KWS

2in 2023

2007high 29 (2008) · low 0 (2009)2026

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

Adverse event reports per year · KWS

2,281in 2025

2007high 2,281 (2025) · low 158 (2007)2025

MAUDE reports naming product code KWS, 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	2	—	21	158
2008	4	37	29	238
2009	4	108	0	294
2010	7	33	10	393
2011	11	90	11	486
2012	7	86	10	542
2013	12	120	0	818
2014	7	89	1	1,066
2015	8	129	0	1,170
2016	10	114	1	970
2017	7	120	4	1,681
2018	4	152	1	1,545
2019	9	106	2	1,728
2020	3	98	5	1,567
2021	5	151	0	1,358
2022	5	158	0	1,268
2023	4	250	2	1,750
2024	2	—	0	2,122
2025	3	97	0	2,281
2026	2	—	1	—

What is it indicated for?

The packaging change which is the subject of this submission does not affect the intended uses of any of the commercially available UHMWPE components subject to the packaging change.

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/K955944 · printed Nov 5, 2026

Cite this page

510(k) Report. “K955944: Osteonics N2/Vac Packaging Process.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955944

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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