510(k) · Cleared

Recalled · Class II · 2016

CPT 12/14 Hip Prostheses, Model 00-8114-040/050-00

K030265510(k) SpecialCleared Mar 4, 200336-day reviewClass II21 CFR 888.3350Recalls 3

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

Zimmer, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Mar 4, 2003 as substantially equivalent to K960658 (Zimmer, Inc., 1996) after a 36-day review. Its family tree reaches back 1 generation to 1996. 10 later devices descend from it. It has been recalled 3 times.

Decided: Mar 4, 2003
Review: 36 days
Class: Class II
Product code: JDI
Recalls: 3
Predicates: 1

Its longest line of descent runs back 1 generation to K960658 (1996). 10 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK960658 Collarless Polished Taper Hip ProsthesisZimmer, Inc. · 1996 · Recalled
This deviceK030265 CPT 12/14 Hip Prostheses, Model 00-8114-040/050-00Zimmer, Inc. · 2003
Descendant · cites it directly · 3 of its ownK060040 Zimmer M/L Taper Hip ProsthesisZimmer, Inc. · 2006 · Recalled
Descendant · cites it directly · 2 of its ownK191735 CPT Hip SystemZimmer, Inc. · 2020
Descendant · 2 generations on · 2 of its ownK192660 Zimmer M/L Taper Hip ProsthesisZimmer, Inc. · 2020
Descendant · cites it directly · 2 of its ownK152530 UCP StemUnited Orthopedic Corporation · 2016
Descendant · 2 generations on · 1 of its ownK200823 Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · Recalled

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2006high 4 (2020) · low 0 (2007)2026

Most influential descendants

Showing 5 of 10 · See all

K060040Zimmer M/L Taper Hip ProsthesisZimmer, Inc. · 2006 · cites it directly3descendants
K191735CPT Hip SystemZimmer, Inc. · 2020 · cites it directly2descendants
K192660Zimmer M/L Taper Hip ProsthesisZimmer, Inc. · 2020 · 2 generations on2descendants
K152530UCP StemUnited Orthopedic Corporation · 2016 · cites it directly2descendants
K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K960658	Collarless Polished Taper Hip Prosthesis	Zimmer, Inc.	1996	14
0 (this device)	K030265	CPT 12/14 Hip Prostheses, Model 00-8114-040/050-00	Zimmer, Inc.	2003	—
+1	K060040	Zimmer M/L Taper Hip Prosthesis	Zimmer, Inc.	2006	2
+1	K191735	CPT Hip System	Zimmer, Inc.	2020	—
+2	K192660	Zimmer M/L Taper Hip Prosthesis	Zimmer, Inc.	2020	—
+1	K152530	UCP Stem	United Orthopedic Corporation	2016	—
+2	K200823	Zimmer, Inc. Hip Joint Prostheses MR Labeling I	Zimmer, Inc.	2020	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2015	1	0
2016	2	0
2020	4	0
2025	2	0

FIG. 1 — Lineage of K030265, 1996–2025Source: 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

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What was it cleared against? (1)

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
*	K960658	Collarless Polished Taper Hip Prosthesis Summary page 1 …Polished Taper and Collarless Polished Taper LS Hip Prostheses, manufactured by Zimmer, K960658, cleared July 16, 1996. Device Description: The CP TO 12/14, like its predicate, is a one-piece…	Zimmer, Inc.	1996	14

Also cleared against K960658: 4 other devices →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K060040	Zimmer M/L Taper Hip Prosthesis	Zimmer, Inc.	2006	3
K191735	CPT Hip System	Zimmer, Inc.	2020	2
K152530	UCP Stem	United Orthopedic Corporation	2016	2
K140547	Excera Fitrite Total Hip Arthroplasty System	Excera Orthopedics, Inc.	2015	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 11, 2016	Class II	Z-0843-2016	Process control	LDPE bag containing the implant adheres to the highly polished implant surface.
Jan 11, 2016	Class II	Z-1120-2016	Packaging	As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Oct 11, 2013	Class II	Z-1032-2014	Packaging	Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K060040 (Zimmer, Inc., 2006) has gone furthest, with 3 descendants of its own.
4 other devices also cite its predicate K960658.

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?

The CPTB 12/14 Hip Prostheses are indicated for use with patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur and in the presence of proximal femoral bone defects; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses andor total hip components in the affected extremity; and patients with acute femoral neck fractures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030265 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030265: CPT 12/14 Hip Prostheses, Model 00-8114-040/050-00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030265

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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