510(k) · Cleared

Recalled · Class II · 2012

Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating

K980711510(k) TraditionalCleared Nov 12, 1998261-day reviewClass II21 CFR 888.3358Recalls 1

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 Nov 12, 1998 as substantially equivalent to K840643 (Zimmer, Inc., 1984) and 3 other predicates after a 261-day review. Its family tree reaches back 2 generations to 1994. 309 later devices descend from it. It has been recalled once.

Decided: Nov 12, 1998
Review: 261 days
Class: Class II
Product code: LPH
Recalls: 1
Predicates: 4

Its longest line of descent runs back 2 generations to K941847 (1994). 6 ancestors in all, the oldest K840643 (1984). 309 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
1 generation backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
This deviceK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998
Descendant · cites it directly · 296 of its ownK030733 Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · Recalled
Descendant · 2 generations on · 267 of its ownK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
Descendant · cites it directly · 213 of its ownK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
Descendant · 2 generations on · 207 of its ownK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
Descendant · 3 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled

Showing 5 of 309 descendants. See all descendants

Descendants cleared per year

2000high 26 (2012) · low 0 (2002)2026

Most influential descendants

Showing 5 of 309 · See all

K030733Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · cites it directly296descendants
K040191Bicontact Hip Stem and Femoral HeadAesculap · 2004 · 2 generations on267descendants
K001277Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000 · cites it directly213descendants
K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003 · 2 generations on207descendants
K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 3 generations on198descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K941847	5/8 Porocoat Aml Hip Porocoat Porous Coating	Depuy, Inc.	1994	—
−1	K964650	TCP-Coated Porocoat Aml Femoral Hip Prosthesis	Depuy, Inc.	1997	—
0 (this device)	K980711	Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating	Zimmer, Inc.	1998	—
+1	K030733	Mayo Conservative Hip Prosthesis, Model 8026 Series	Zimmer, Inc.	2003	2
+2	K040191	Bicontact Hip Stem and Femoral Head	Aesculap	2004	—
+1	K001277	Triflange Acetabular Cup System	DePuy Orthopaedics, Inc.	2000	—
+2	K031495	Pinnacle Duofix HA Acetabular Cup Prosthesis	DePuy Orthopaedics, Inc.	2003	—
+3	K042344	Excia Total Hip System	Aesculap, Inc.	2005	10

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1984	1	0
1994	1	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2001	1	0
2003	2	0
2004	3	0
2005	1	0
2006	6	0
2007	1	0
2008	9	0
2009	5	0
2010	7	0
2011	16	0
2012	26	0
2013	23	0
2014	8	0
2015	9	0
2016	11	0
2017	17	0
2018	17	0
2019	15	0
2020	16	0
2021	19	0
2022	18	0
2023	20	0
2024	16	0
2025	22	0
2026	20	0

FIG. 1 — Lineage of K980711, 1994–2026Source: 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 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 24.2 · 20 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
*	K840643	Harris-Galante Porous Total Hip Sys Summary page 1 …Prosthesis ) Classification Name: - Hip Joint Metal/Polymer/Metal Semiconstrained Porous-Coated Uncemented Prosthesis Stems: > Harris/Galante Porous Hip Prosthesis, K-840643, cleared April 17, 1984 A 4 Brictol . w A Bristol-Myers Squibb Company L= S e > TCP-Coated Porocoat AML Femoral…	Zimmer, Inc.	1984	8
*	K964650	TCP-Coated Porocoat Aml Femoral Hip Prosthesis Summary page 2 …Prosthesis, K-840643, cleared April 17, 1984 A 4 Brictol . w A Bristol-Myers Squibb Company L= S e > TCP-Coated Porocoat AML Femoral Hip Prosthesis, K-964650, cleared June 6, 1997 Acetabular Cups: > HGP II Acetabular Stem, K-921308, cleared February 22, 1994 > Inter-Op HA Porous Aceta…	Depuy, Inc.	1997	—
*	K921308	HG Multilock Hip Prosthesis W/ TI-Nidium Summary page 2 …ers Squibb Company L= S e > TCP-Coated Porocoat AML Femoral Hip Prosthesis, K-964650, cleared June 6, 1997 Acetabular Cups: > HGP II Acetabular Stem, K-921308, cleared February 22, 1994 > Inter-Op HA Porous Acetabular System, K-972393, cleared September 19, 1997 Device Description The…	Zimmer, Inc.	1994	1
*	K972393	Inter-OP HA Porous Acetabular System (HA/Csti) Summary page 2 …Hip Prosthesis, K-964650, cleared June 6, 1997 Acetabular Cups: > HGP II Acetabular Stem, K-921308, cleared February 22, 1994 > Inter-Op HA Porous Acetabular System, K-972393, cleared September 19, 1997 Device Description The hydroxyapatite tricalcium phosphate coated HGP Total Hip System is modular i…	Sulzer Orthopedics, Inc.	1997	—

What descends from it? (309)

See all 309

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

Number	Device	Applicant	Decided	Descendants
K030733	Mayo Conservative Hip Prosthesis, Model 8026 Series	Zimmer, Inc.	2003	296
K001277	Triflange Acetabular Cup System	DePuy Orthopaedics, Inc.	2000	213
K011489	Summit Duofix Hip Prosthesis	DePuy Orthopaedics, Inc.	2001	40

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 14, 2012	Class II	Z-0770-2013	Process control	Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
2 of the 5 ancestors have a recall of any class.
Of its descendants, K030733 (Zimmer, Inc., 2003) has gone furthest, with 296 descendants of its own.

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 Harris/Galante Hip Prosthesis is designed for implantation into the human joint in 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…

Read the full statement (151 words)

The Harris/Galante Hip Prosthesis is designed for implantation into the human joint in 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/or total hip components in the affected extremity 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/K980711 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980711: Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980711

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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