510(k) · Cleared

Cleared

36MM C-Taper Femoral Head Components (Lfit and Non-Lfit)

K021310510(k) SpecialCleared May 21, 200226-day reviewClass II21 CFR 888.3350

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 May 21, 2002 as substantially equivalent to K910988 (Osteonics Corp., 1991) and 2 other predicates after a 26-day review. Its family tree reaches back 1 generation to 1990. 55 later devices descend from it.

Decided: May 21, 2002
Review: 26 days
Class: Class II
Product code: JDI
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K900836 (1990). 3 ancestors in all. 55 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK900836 Osteonics Ecsi Hip Stem SeriesOsteonics Corp. · 1990
This deviceK021310 36MM C-Taper Femoral Head Components (Lfit and Non-Lfit)Howmedica Osteonics Corp. · 2002
Descendant · cites it directly · 54 of its ownK061434 Trident Large Diameter Hip SystemHowmedica Osteonics Corp. · 2006 · Recalled
Descendant · 2 generations on · 37 of its ownK110290 Exeter Hip StemHowmedica Osteonics Corp. · 2011 · Recalled
Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
Descendant · 2 generations on · 16 of its ownK093363 Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010
Descendant · 2 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled

Showing 5 of 55 descendants. See all descendants

Descendants cleared per year

2006high 9 (2022) · low 0 (2007)2026

Most influential descendants

Showing 5 of 55 · See all

K061434Trident Large Diameter Hip SystemHowmedica Osteonics Corp. · 2006 · cites it directly54descendants
K110290Exeter Hip StemHowmedica Osteonics Corp. · 2011 · 2 generations on37descendants
K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010 · 2 generations on16descendants
K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 2 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K900836	Osteonics Ecsi Hip Stem Series	Osteonics Corp.	1990	—
0 (this device)	K021310	36MM C-Taper Femoral Head Components (Lfit and Non-Lfit)	Howmedica Osteonics Corp.	2002	—
+1	K061434	Trident Large Diameter Hip System	Howmedica Osteonics Corp.	2006	2
+2	K110290	Exeter Hip Stem	Howmedica Osteonics Corp.	2011	1
+1	K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016	1
+2	K093363	Cocr and Oxinium Femoral Heads and R3 Xlpe Liners	Smith & Nephew, Inc.	2010	—
+2	K173499	Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads	Stryker Orthopaedics	2018	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2010	1	0
2011	2	0
2012	1	0
2013	1	0
2015	1	0
2016	5	0
2017	2	0
2018	4	0
2019	5	0
2020	2	0
2021	3	0
2022	9	0
2023	5	0
2024	5	0
2025	4	0
2026	4	0

FIG. 1 — Lineage of K021310, 1990–2026Source: 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? (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
*	K910988	Osteonics Ion Implanted Femoral Bearing Series Summary page 1 …evice are identical to those of predicate devices. The predicate LFIT™ C- Taper femoral bearing components were found substantially equivalent via the 510(k) process in K910988 up to the size +10mm offset head. The non- LFIT™ C- Taper femoral head components were cleared in 510(k) number K900836 up to the…	Osteonics Corp.	1991	—
*	K900836	Osteonics Ecsi Hip Stem Series Summary page 1 …ubstantially equivalent via the 510(k) process in K910988 up to the size +10mm offset head. The non- LFIT™ C- Taper femoral head components were cleared in 510(k) number K900836 up to the size +10mm offset head. ‘The +12mm and +15mm offset head components in both the non- LFIT™ and LFIT™ versions were foun…	Osteonics Corp.	1990	—
*	K982936	Osteonics Extended Femoral Bearing Head Summary page 1 …36 up to the size +10mm offset head. ‘The +12mm and +15mm offset head components in both the non- LFIT™ and LFIT™ versions were found substantially equivalent in 510(k) #K982936. The C- Taper femoral head components are fabricated from cobalt chromium alloy conforming to ASTM F1537. Like the predicate devi…	Osteonics Corp.	1998	—

Also cleared against K910988: 4 other devices →

What descends from it? (55)

See all 55

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

Number	Device	Applicant	Decided	Descendants
K061434	Trident Large Diameter Hip System	Howmedica Osteonics Corp.	2006	54
K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016	17

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.
Of its descendants, K061434 (Howmedica Osteonics Corp., 2006) has gone furthest, with 54 descendants of its own.
4 other devices also cite its predicate K910988.

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?

Indications for use as part of a Universal Hip Replacement include:

• Femoral neck fractures;

• Non-union of femoral head and neck fractures,

• Aseptic necrosis of the femoral head as well as;

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

Indications for use as part of a Total Hip Replacement include:

• Severely disabled joints resulting from painful osteo-, rheumatoid, post-traumatic arthritis and late stages of avascular necrosis;

• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure as well as;

• Other difficult clinical management problems.

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/K021310 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021310: 36MM C-Taper Femoral Head Components (Lfit and Non-Lfit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021310

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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