510(k) · Cleared

Cleared

Modification to V-40/C-Taper Adapter Sleeve

K051737510(k) SpecialCleared Jul 19, 200521-day reviewClass II21 CFR 888.3353

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

Howmedica Osteonics Corp. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Jul 19, 2005 after a 21-day review. The FDA summary names no predicate by number. 59 later devices descend from it.

Decided: Jul 19, 2005
Review: 21 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 0

59 later devices descend from it, 3 citing it directly.

This deviceK051737 Modification to V-40/C-Taper Adapter SleeveHowmedica Osteonics Corp. · 2005
Descendant · cites it directly · 25 of its ownK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
Descendant · 2 generations on · 16 of its ownK143407 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2014
Descendant · 2 generations on · 14 of its ownK141972 Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
Descendant · cites it directly · 14 of its ownK071830 Depuy Delta TS Ceramic Femoral HeadsDePuy Orthopaedics, Inc. · 2007 · Recalled

Showing 5 of 59 descendants. See all descendants

Descendants cleared per year

2007high 8 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 59 · See all

K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010 · cites it directly25descendants
K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2014 · 2 generations on16descendants
K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014 · 2 generations on14descendants
K071830Depuy Delta TS Ceramic Femoral HeadsDePuy Orthopaedics, Inc. · 2007 · cites it directly14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K051737	Modification to V-40/C-Taper Adapter Sleeve	Howmedica Osteonics Corp.	2005	—
+1	K100445	Klassic HD Hip System	Total Joint Orthopedics, Inc.	2010	—
+1	K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016	1
+2	K143407	Klassic HD Hip System	Total Joint Othopedics, Inc.	2014	—
+2	K141972	Klassic HD Acetabular Insert with E-Link Poly	Total Joint Orthopedics, Inc.	2014	—
+1	K071830	Depuy Delta TS Ceramic Femoral Heads	DePuy Orthopaedics, Inc.	2007	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2010	1	0
2013	1	0
2014	5	0
2015	2	0
2016	2	0
2017	3	0
2018	4	0
2019	4	0
2020	2	0
2021	4	0
2022	7	0
2023	4	0
2024	5	0
2025	8	0
2026	5	0

FIG. 1 — Lineage of K051737, 2005–2026Source: 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 LZO? 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 LZO device

#1 K192827 Quadra-Pscore 19.3 · 10 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?

The FDA summary names no predicate by number.

What descends from it? (59)

See all 59

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K100445	Klassic HD Hip System	Total Joint Orthopedics, Inc.	2010	25
K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016	17
K071830	Depuy Delta TS Ceramic Femoral Heads	DePuy Orthopaedics, Inc.	2007	14

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?

Of its descendants, K100445 (Total Joint Orthopedics, Inc., 2010) has gone furthest, with 25 descendants of its own.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZO

14in 2025

2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007high 42 (2009) · low 0 (2010)2026

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

Adverse event reports per year · LZO

3,244in 2025

2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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	9	87	2	138
2008	11	63	13	125
2009	7	83	42	189
2010	15	78	0	394
2011	13	87	10	544
2012	14	98	14	963
2013	26	100	0	1,370
2014	13	85	1	1,477
2015	12	115	1	1,348
2016	10	177	9	1,728
2017	16	257	5	2,165
2018	18	163	2	3,133
2019	28	109	4	3,066
2020	18	112	3	1,963
2021	12	170	0	2,199
2022	11	279	4	1,985
2023	10	122	2	2,066
2024	11	111	1	2,586
2025	14	119	1	3,244
2026	9	102	0	—

What is it indicated for?

The indications for use of the subject device, in keeping with those of other legally marketed Howmedica Osteonics' adapter sleeves is as follows: For Use as a Total Hip Replacement * Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage vascular necrosis. · Revision of previous cup arthroplasty or other procedures. Clinical management problems where arthrodesis or…

Read the full statement (143 words)

The indications for use of the subject device, in keeping with those of other legally marketed Howmedica Osteonics' adapter sleeves is as follows:

For Use as a Total Hip Replacement

* Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage vascular necrosis.

· Revision of previous cup arthroplasty or other procedures.

Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

For Use as a Bipolar Hip Replacement

Femoral head/neck fractures or non-unions.

Aseptic necrosis of the femoral head.

Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Other Considerations:

* Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.

* Salvage of failed total hip arthroplasty.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051737 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051737: Modification to V-40/C-Taper Adapter Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051737

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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