510(k) · Cleared

Recalled · Class II · 2018

36MM V40 Femoral Head Components (Lfit and Non-Lfit)

K022077510(k) SpecialCleared Jul 25, 200229-day reviewClass II21 CFR 888.3350Recalls 12

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

Howmedica Osteonics Corp. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Jul 25, 2002 as substantially equivalent to K010757 (Howmedica Osteonics Corp., 2001) and 3 other predicates after a 29-day review. Its family tree reaches back 2 generations to 1991. 298 later devices descend from it. It has been recalled 12 times.

Decided: Jul 25, 2002
Review: 29 days
Class: Class II
Product code: JDI
Recalls: 12
Predicates: 4

Its longest line of descent runs back 2 generations to K910988 (1991). 5 ancestors in all. 298 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 2 generations backK910988 Osteonics Ion Implanted Femoral Bearing SeriesOsteonics Corp. · 1991
1 generation backK010757 Lfit V40 Femoral Head ComponentsHowmedica Osteonics Corp. · 2001 · Recalled
This deviceK022077 36MM V40 Femoral Head Components (Lfit and Non-Lfit)Howmedica Osteonics Corp. · 2002
Descendant · cites it directly · 267 of its ownK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
Descendant · cites it directly · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
Descendant · 2 generations on · 166 of its ownK043079 Bicontact Hip System with U-CapAesculap · 2004
Descendant · 3 generations on · 117 of its ownK093472 Trinity Acetabular SystemCorin USA · 2010 · Recalled
Descendant · 4 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011

Showing 5 of 298 descendants. See all descendants

Descendants cleared per year

2004high 22 (2012) · low 1 (2005)2026

Most influential descendants

Showing 5 of 298 · See all

K040191Bicontact Hip Stem and Femoral HeadAesculap · 2004 · cites it directly267descendants
K042344Excia Total Hip SystemAesculap, Inc. · 2005 · cites it directly198descendants
K043079Bicontact Hip System with U-CapAesculap · 2004 · 2 generations on166descendants
K093472Trinity Acetabular SystemCorin USA · 2010 · 3 generations on117descendants
K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 4 generations on109descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K910988	Osteonics Ion Implanted Femoral Bearing Series	Osteonics Corp.	1991	—
−1	K010757	Lfit V40 Femoral Head Components	Howmedica Osteonics Corp.	2001	4
0 (this device)	K022077	36MM V40 Femoral Head Components (Lfit and Non-Lfit)	Howmedica Osteonics Corp.	2002	—
+1	K040191	Bicontact Hip Stem and Femoral Head	Aesculap	2004	—
+1	K042344	Excia Total Hip System	Aesculap, Inc.	2005	10
+2	K043079	Bicontact Hip System with U-Cap	Aesculap	2004	—
+3	K093472	Trinity Acetabular System	Corin USA	2010	1
+4	K110087	Corin Trinity Acetbular System with Hxlpe Liners	Corin USA	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	1	0
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	1	0
2006	6	0
2007	1	0
2008	6	0
2009	5	0
2010	7	0
2011	16	0
2012	22	0
2013	21	0
2014	7	0
2015	7	0
2016	12	0
2017	17	0
2018	18	0
2019	17	0
2020	17	0
2021	20	0
2022	22	0
2023	18	0
2024	15	0
2025	22	0
2026	19	0

FIG. 1 — Lineage of K022077, 1991–2026Source: 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 JDI? 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 JDI device

#1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (4)

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
*	K010757	Lfit V40 Femoral Head Components Summary page 1 …ect device are identical to those of predicate devices. The predicate LFITTMV40TMfemoral bearing components were found substantially equivalent via the 510(k) process in K010757. The non-LFITTMV40TMfemoral head components were cleared in 5 1O(k) numbers: K936126, K950541, and K993601. The V40TMfemoral head…	Howmedica Osteonics Corp.	2001	4
*	K936126	Howmedics DRG Femoral Component Summary page 1 …ral bearing components were found substantially equivalent via the 510(k) process in K010757. The non-LFITTMV40TMfemoral head components were cleared in 5 1O(k) numbers: K936126, K950541, and K993601. The V40TMfemoral head components are fabricated from Cobalt Chromium Alloy conforming to ASTM F1537. Like…	Howmedica, Inc.	1994	—
*	K950541	Howmedica V40 22MM Femoral Head Summary page 1 …ng components were found substantially equivalent via the 510(k) process in K010757. The non-LFITTMV40TMfemoral head components were cleared in 5 1O(k) numbers: K936126, K950541, and K993601. The V40TMfemoral head components are fabricated from Cobalt Chromium Alloy conforming to ASTM F1537. Like the predi…	Howmedica Corp.	1995	—
*	K993601	Howmedica Osteonics Femoral Heads Summary page 1 …were found substantially equivalent via the 510(k) process in K010757. The non-LFITTMV40TMfemoral head components were cleared in 5 1O(k) numbers: K936126, K950541, and K993601. The V40TMfemoral head components are fabricated from Cobalt Chromium Alloy conforming to ASTM F1537. Like the predicate devices,…	Howmedica Osteonics Corp.	1999	3

Also cleared against K010757: 4 other devices →

What descends from it? (298)

See all 298

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

Number	Device	Applicant	Decided	Descendants
K040191	Bicontact Hip Stem and Femoral Head	Aesculap	2004	267
K042344	Excia Total Hip System	Aesculap, Inc.	2005	198
K061434	Trident Large Diameter Hip System	Howmedica Osteonics Corp.	2006	54
K110290	Exeter Hip Stem	Howmedica Osteonics Corp.	2011	37
K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016	17
K162125	MALUC™ Total Hip Arthroplasty System	Surgtech, Inc.	2017	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 22, 2018	Class II	Z-2294-2018	Process control	The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
May 22, 2018	Class II	Z-2297-2018	Process control	The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
May 22, 2018	Class II	Z-2293-2018	Process control	The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
May 22, 2018	Class II	Z-2299-2018	Process control	The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
May 22, 2018	Class II	Z-2295-2018	Process control	The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
May 22, 2018	Class II	Z-2292-2018	Process control	The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
May 22, 2018	Class II	Z-2296-2018	Process control	The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
May 22, 2018	Class II	Z-2298-2018	Process control	The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
Aug 29, 2016	Class II	Z-0378-2017	Under Investigation by firm	Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads.
Sep 4, 2009	Not classified	Z-0390-2010	Process control	Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.
Sep 4, 2009	Not classified	Z-0391-2010	Process control	Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.
Jun 18, 2009	Not classified	Z-1822-2009	Process control	Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width.

The 5 latest of 12 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 10.0 years on median.
2 of the 5 ancestors have a recall of any class.
Of its descendants, K040191 (Aesculap, 2004) has gone furthest, with 267 descendants of its own.
4 other devices also cite its predicate K010757.

How does its category compare?

All JDI devices

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

FDA decisions per year · JDI

1in 2025

2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007high 247 (2020) · low 59 (2024)2026

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

Recalls per year · JDI

1in 2025

2007high 77 (2020) · low 0 (2021)2026

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

Adverse event reports per year · JDI

1,644in 2025

2007high 7,407 (2019) · low 696 (2007)2025

MAUDE reports naming product code JDI, 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	3	81	26	696
2008	5	96	6	810
2009	3	65	3	964
2010	0	—	3	2,040
2011	2	—	5	3,160
2012	4	167	4	5,122
2013	3	176	11	5,206
2014	3	98	3	4,968
2015	3	190	1	4,906
2016	4	166	5	3,995
2017	1	—	5	6,135
2018	1	—	1	6,728
2019	2	—	1	7,407
2020	7	247	77	4,015
2021	3	162	0	3,170
2022	3	69	0	1,978
2023	2	—	0	1,635
2024	3	59	0	1,821
2025	1	—	1	1,644
2026	2	—	0	—

What is it indicated for?

These devices are modular components of a total hip system. These femoral heads are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022077 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022077: 36MM V40 Femoral Head Components (Lfit and Non-Lfit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022077

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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