510(k) · Cleared

Recalled · 2006

Delta Hip Prosthesis

K961378510(k) TraditionalCleared Oct 8, 1996181-day reviewClass II21 CFR 888.3360Recalls 4

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

Zimmer, Inc. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on Oct 8, 1996 as substantially equivalent to K901687 (Med-Tek Corp., 1990) and 2 other predicates after a 181-day review. Its family tree reaches back 1 generation to 1985. 1 of the 388 devices in its family, counting itself, has a Class I recall. 384 later devices descend from it. It has been recalled 4 times.

Decided: Oct 8, 1996
Review: 181 days
Class: Class II
Product code: LWJ
Recalls: 4
Predicates: 3

Its longest line of descent runs back 1 generation to K850055 (1985). 3 ancestors in all. 384 later devices descend from it, 2 citing it directly. 1 of the 388 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK850055 Profile Femoral HipDepuy, Inc. · 1985
This deviceK961378 Delta Hip ProsthesisZimmer, Inc. · 1996
Descendant · cites it directly · 363 of its ownK964769 Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997
Descendant · 2 generations on · 296 of its ownK030733 Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · Recalled
Descendant · 3 generations on · 267 of its ownK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
Descendant · 4 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
Descendant · 4 generations on · 166 of its ownK043079 Bicontact Hip System with U-CapAesculap · 2004

Showing 5 of 384 descendants. See all descendants

Descendants cleared per year

1997high 29 (2012) · low 0 (2001)2026

Class I recalls in this family

K071856 Zimmer M/L Taper Hip Prosthesis with Kinectiv…4 generations on · 2007

Most influential descendants

Showing 5 of 384 · See all

K964769Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997 · cites it directly363descendants
K030733Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · 2 generations on296descendants
K040191Bicontact Hip Stem and Femoral HeadAesculap · 2004 · 3 generations on267descendants
K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 4 generations on198descendants
K043079Bicontact Hip System with U-CapAesculap · 2004 · 4 generations on166descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K850055	Profile Femoral Hip	Depuy, Inc.	1985	—
0 (this device)	K961378	Delta Hip Prosthesis	Zimmer, Inc.	1996	—
+1	K964769	Versys Hip System--Fiber Metal Taper Hip Prosthesis	Zimmer, Inc.	1997	—
+2	K030733	Mayo Conservative Hip Prosthesis, Model 8026 Series	Zimmer, Inc.	2003	2
+3	K040191	Bicontact Hip Stem and Femoral Head	Aesculap	2004	—
+4	K042344	Excia Total Hip System	Aesculap, Inc.	2005	10
+4	K043079	Bicontact Hip System with U-Cap	Aesculap	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1990	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
1999	2	0
2000	1	0
2003	3	0
2004	4	0
2005	2	0
2006	7	0
2007	3	1
2008	11	0
2009	5	0
2010	9	0
2011	17	0
2012	29	0
2013	26	0
2014	13	0
2015	13	0
2016	16	0
2017	23	0
2018	22	0
2019	24	0
2020	25	0
2021	20	0
2022	20	0
2023	20	0
2024	19	0
2025	25	0
2026	23	0

FIG. 1 — Lineage of K961378, 1985–2026Source: 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.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (7)

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
*	K901687	F-24 Femoral Hip Prosthesis Summary page 1 …Type Total Hip, Charnley Type Total Hip, and Miiller Type Total Hip, manufactured by Zimmer, preenactment devices - F-24 Femoral Hip Prosthesis, manufactured by Astel, K901687, cleared September 7, 1990 - TI-FIT™ Total Hip System, manufactured by Smith & Nephew Richards, K873797, cleared November 2, 198…	Med-Tek Corp.	1990	—
*	K873797	TI-Fit Total Hip System Summary page 1 …t devices - F-24 Femoral Hip Prosthesis, manufactured by Astel, K901687, cleared September 7, 1990 - TI-FIT™ Total Hip System, manufactured by Smith & Nephew Richards, K873797, cleared November 2, 1987 1 170 % A Bristol-Myers Squibb Company Profile™ Total Hip System, manufactured by DeP…	Richards Medical Co., Inc.	1987	—
*	K850055	Profile Femoral Hip Summary page 2 …by Smith & Nephew Richards, K873797, cleared November 2, 1987 1 170 % A Bristol-Myers Squibb Company Profile™ Total Hip System, manufactured by DePuy, K850055, cleared April 23, 1985 - CLS Total Hip Replacement System (Protek, Inc.), distributed by Intermedics Orthopedics, Inc. Device…	Depuy, Inc.	1985	—
*	—	AuFranc-Turner Type Total Hip Named without a submission number			—
*	—	Charnley Type Total Hip Named without a submission number			—
*	—	Miiller Type Total Hip Named without a submission number			—
*	—	CLS Total Hip Replacement System Named without a submission number			—

Also cleared against K901687: 1 other device →

What descends from it? (384)

See all 384

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

Number	Device	Applicant	Decided	Descendants
K964769	Versys Hip System--Fiber Metal Taper Hip Prosthesis	Zimmer, Inc.	1997	363
K992667	ZMR Hip System-Revision Taper	Zimmer, Inc.	1999	114

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 2, 2006	Not classified	Z-1470-06	Other	Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.
Aug 2, 2006	Not classified	Z-1469-06	Other	Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.
Aug 2, 2006	Not classified	Z-1467-06	Other	Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.
Aug 2, 2006	Not classified	Z-1468-06	Other	Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series ( Modular Necks)…Zimmer, Inc. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall

What does this lineage say?

None of the 3 ancestors has a recall.
Of its descendants, K964769 (Zimmer, Inc., 1997) has gone furthest, with 363 descendants of its own.
1 other device also cites its predicate K901687.

How does its category compare?

All LWJ devices

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

FDA decisions per year · LWJ

1in 2012

2007high 2 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LWJ

Too few LWJ 510(k)s in any year since 2007 to give a median.

Recalls per year · LWJ

2in 2023

2007high 10 (2007) · low 0 (2010)2026

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

Adverse event reports per year · LWJ

51in 2025

2007high 522 (2013) · low 51 (2025)2025

MAUDE reports naming product code LWJ, 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	—	10	68
2008	1	—	2	72
2009	1	—	2	84
2010	0	—	0	132
2011	1	—	0	255
2012	1	—	0	390
2013	0	—	1	522
2014	0	—	0	452
2015	0	—	0	310
2016	0	—	0	293
2017	0	—	0	311
2018	0	—	0	227
2019	0	—	0	210
2020	0	—	0	189
2021	0	—	0	155
2022	0	—	0	91
2023	0	—	2	72
2024	0	—	0	54
2025	0	—	0	51
2026	0	—	0	—

What is it indicated for?

The Delta Hip Prosthesis is designed for press-fit fixation into the human femur as a component in either total hip or hemi-hip replacement and is indicated for the following: Total Hip Replacement Severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio…

Read the full statement (148 words)

The Delta Hip Prosthesis is designed for press-fit fixation into the human femur as a component in either total hip or hemi-hip replacement and is indicated for the following:

Total Hip Replacement

Severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and acute femoral neck fractures.

Hemi-Hip Replacement

Fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

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/K961378 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961378: Delta Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961378

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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