510(k) · Cleared

Cleared

Epoch Hip Prosthesis, Model 4075 Series

K014070510(k) TraditionalCleared Jul 30, 2002232-day reviewClass II21 CFR 888.3358

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

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

Cleared on Jul 30, 2002 as substantially equivalent to K931641 (Depuy, Inc., 1994) and 4 other predicates after a 232-day review. Its family tree reaches back 1 generation to 1984. 2 later devices descend from it.

Decided: Jul 30, 2002
Review: 232 days
Class: Class II
Product code: LPH
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K842906 (1984). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK842906 Bias Total HipZimmer, Inc. · 1984
This deviceK014070 Epoch Hip Prosthesis, Model 4075 SeriesZimmer, Inc. · 2002
Descendant · cites it directly · 1 of its ownK052321 Versys Epoch Fullcoat Hip ProsthesisZimmer, Inc. · 2006
Descendant · 2 generations on · 0 of its ownK073499 Versys Epoch Fullcoat Hip Prosthesis, Model 4088 SeriesZimmer, Inc. · 2008

Most influential descendants

Showing 2 of 2 · See all

K052321Versys Epoch Fullcoat Hip ProsthesisZimmer, Inc. · 2006 · cites it directly1descendant
K073499Versys Epoch Fullcoat Hip Prosthesis, Model 4088 SeriesZimmer, Inc. · 2008 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K842906	Bias Total Hip	Zimmer, Inc.	1984	—
0 (this device)	K014070	Epoch Hip Prosthesis, Model 4075 Series	Zimmer, Inc.	2002	—
+1	K052321	Versys Epoch Fullcoat Hip Prosthesis	Zimmer, Inc.	2006	—
+2	K073499	Versys Epoch Fullcoat Hip Prosthesis, Model 4088 Series	Zimmer, Inc.	2008	—

Other ancestors by year cleared

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0

FIG. 1 — Lineage of K014070, 1984–2008Source: 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 LPH? 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 LPH device

#1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 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? (5)

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
*	P820024	Prosthesis, Hip, Hemi-Femoral, Metal FDA lists this PMA only through its supplements; the earliest we hold is P820024/S001 (Mar 16, 1984). Summary page 1 …on Name: Prosthesis, hip, semi-constrained,composite1polymer 0 Predicate Devices: e AML Total Hip System with Porocoat, manufactured by DePuy, P820024, approved for use without bone cement August 19, 1983 (formerly called the Porocoat Modified Austin-Moore…	Depuy, Inc.		—
*	K931641	Porocoat Porous Coating Summary page 1 …d for use without bone cement August 19, 1983 (formerly called the Porocoat Modified Austin-Moore Total Hip Prosthesis); Porocoat Porous Coating, K93 1641, cleared for use without bone cement March 2 1, 1994 0 BIAS@ Total Hip System, manufactured by Zimmer,…	Depuy, Inc.	1994	—
*	K842906	Bias Total Hip Summary page 2 …at Porous Coating, K93 1641, cleared for use without bone cement March 2 1, 1994 0 BIAS@ Total Hip System, manufactured by Zimmer, K842906, cleared for use with bone cement August 24, 1984; P850061, approved for use without bone cement Januar…	Zimmer, Inc.	1984	—
*	P850061	Bias (R) Fiber Metal Total Hip System FDA lists this PMA only through its supplements; the earliest we hold is P850061/S001 (Mar 29, 1989). Summary page 2 …ment March 2 1, 1994 0 BIAS@ Total Hip System, manufactured by Zimmer, K842906, cleared for use with bone cement August 24, 1984; P850061, approved for use without bone cement January 3 1, 1989, subsequently downclassified to Class I1 on February…	Zimmer, Inc.		—
*	K934515	Bias (TM) Fiber Metal Total Hip Stem (TFB) Summary page 2 …January 3 1, 1989, subsequently downclassified to Class I1 on February 21; 1992 0 BIAS Fiber Metal Total Hip Stem (TFB), manufactured by Zimmer, K934515, cleared August 24, 1995 0 Device Description The Epoch Hip Prosthesis is a femoral stem manufactured from c…	Zimmer, Inc.	1995	—

Also cleared against P820024: 3 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K052321	Versys Epoch Fullcoat Hip Prosthesis	Zimmer, Inc.	2006	1

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, K052321 (Zimmer, Inc., 2006) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate P820024.

How does its category compare?

All LPH devices

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

FDA decisions per year · LPH

12in 2025

2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007high 410 (2021) · low 76 (2012)2026

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

Recalls per year · LPH

4in 2025

2007high 30 (2012) · low 1 (2008)2026

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

Adverse event reports per year · LPH

6,163in 2025

2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, 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	10	116	16	509
2008	10	86	1	706
2009	3	112	2	1,156
2010	15	100	22	2,007
2011	16	110	26	3,320
2012	25	76	30	3,785
2013	11	135	9	5,002
2014	20	129	3	5,163
2015	18	111	1	5,830
2016	10	150	8	4,900
2017	12	121	14	5,312
2018	9	145	2	5,954
2019	22	164	8	7,130
2020	7	164	6	5,429
2021	8	410	4	5,978
2022	14	247	2	5,223
2023	10	111	2	5,345
2024	6	92	1	5,626
2025	12	153	4	6,163
2026	8	256	2	—

What is it indicated for?

The Epoch@ Hip Prosthesis is indicated for:

1. 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.

2. Patients with congenital hip displasia, protrusio acetabuli, or slipped capital femoral epiphysis.

3. Patients suffering from disability due to previous fusion.

4. Patients with acute femoral neck fractures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K014070 · printed Nov 4, 2026

Cite this page

510(k) Report. “K014070: Epoch Hip Prosthesis, Model 4075 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K014070

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026