510(k) · Cleared

Recalled · Class II · 2021

Ecofit® Hip System

K163577510(k) TraditionalCleared Sep 25, 2017279-day reviewClass II21 CFR 888.3353Recalls 1

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

Implantcast GmbH · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Sep 25, 2017 as substantially equivalent to K101086 (Biomet, Inc., 2010) and 15 other predicates after a 279-day review. Its family tree reaches back 11 generations to 1994. 9 later devices descend from it. It has been recalled once.

Decided: Sep 25, 2017
Review: 279 days
Class: Class II
Product code: LZO
Recalls: 1
Predicates: 16

Its longest line of descent runs back 11 generations to K931641 (1994). 286 ancestors in all, the oldest K810258 (1981). 9 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 11 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
7 generations between
3 generations backK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
2 generations backK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
1 generation backK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
This deviceK163577 Ecofit® Hip SystemImplantcast GmbH · 2017
Descendant · cites it directly · 5 of its ownK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
Descendant · cites it directly · 4 of its ownK203420 EcoFit® Hip SystemImplantcast GmbH · 2021
Descendant · cites it directly · 3 of its ownK210678 implaFit® hip stemsImplantcast GmbH · 2022
Descendant · cites it directly · 1 of its ownK240834 EcoFit® short stem cementless cpTiImplantcast GmbH · 2024
Descendant · 2 generations on · 1 of its ownK232371 Actinia® hip stemsImplantcast GmbH · 2023

Show all 11 generations

Root · 11 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
10 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
9 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
8 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
7 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
6 generations backK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
5 generations backK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
4 generations backK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
3 generations backK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
2 generations backK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
1 generation backK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
This deviceK163577 Ecofit® Hip SystemImplantcast GmbH · 2017

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2018high 3 (2026) · low 0 (2019)2026

Most influential descendants

Showing 5 of 9 · See all

K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018 · cites it directly5descendants
K203420EcoFit® Hip SystemImplantcast GmbH · 2021 · cites it directly4descendants
K210678implaFit® hip stemsImplantcast GmbH · 2022 · cites it directly3descendants
K240834EcoFit® short stem cementless cpTiImplantcast GmbH · 2024 · cites it directly1descendant
K232371Actinia® hip stemsImplantcast GmbH · 2023 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−11	K931641	Porocoat Porous Coating	Depuy, Inc.	1994	—
−10	K003800	Aml Hip Prosthesis	DePuy Orthopaedics, Inc.	2001	—
−9	K012364	Aml Hip Prosthesis	DePuy Orthopaedics, Inc.	2001	—
−8	K030236	Acumatch P-Series Porous Press-Fit Femoral Component	Exactech, Inc.	2003	—
−7	K041906	Exactech 12/14 Total Hip System	Exactech, Inc.	2004	1
−6	K042842	Novation 12/14 Press-Fit Femoral Stem	Exactech, Inc.	2004	—
−5	K102487	Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma…	Exactech, Inc.	2010	—
−4	K112802	Pipeline Total Hip System	Pipeline Orthopedics	2012	—
−3	K122158	PBP Total Hip System	Pipeline Biomedical Products, LLC	2012	—
−2	K131237	Pipeline Total Hip System	Pipeline Orthopedics	2013	—
−1	K161184	iNSitu Total Hip System	Theken Companies, LLC	2016	—
0 (this device)	K163577	Ecofit® Hip System	Implantcast GmbH	2017	—
+1	K180263	EcoFit Vit E Acetabular System	Implantcast GmbH	2018	—
+1	K203420	EcoFit® Hip System	Implantcast GmbH	2021	—
+1	K210678	implaFit® hip stems	Implantcast GmbH	2022	—
+1	K240834	EcoFit® short stem cementless cpTi	Implantcast GmbH	2024	—
+2	K232371	Actinia® hip stems	Implantcast GmbH	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1983	1	0
1984	1	0
1985	4	0
1986	3	0
1987	2	0
1988	3	0
1990	2	0
1991	4	0
1992	6	0
1993	6	0
1994	30	0
1995	22	0
1996	26	0
1997	15	0
1998	14	0
1999	14	0
2000	27	0
2001	10	0
2002	13	0
2003	13	0
2004	8	0
2005	12	0
2006	8	0
2007	6	0
2008	6	0
2009	2	0
2010	5	0
2011	4	0
2012	2	0
2013	2	0
2014	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0
2021	1	0
2022	1	0
2023	2	0
2024	1	0
2026	3	0

FIG. 1 — Lineage of K163577, 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 LZO? 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 LZO device

#1 K192827 Quadra-Pscore 19.3 · 10 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? (16)

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
*	K101086	Taperloc Complete Summary page 4 …or nonporous uncemented prosthesis. PREDICATE DEVICES:  Biomet Taperloc® Complete (K101086, K103755)  Zimmer® M/L Taper Hip Prosthesis (K032726)  Biomet Taperloc® Complete Size 4mm and XR 12…	Biomet, Inc.	2010	—
*	K103755	Taperloc Complete, Size 5 and 6 Summary page 4 …or nonporous uncemented prosthesis. PREDICATE DEVICES:  Biomet Taperloc® Complete (K101086, K103755)  Zimmer® M/L Taper Hip Prosthesis (K032726)  Biomet Taperloc® Complete Size 4mm and XR 123° (K1200…	Biomet Manufacturing Corp	2011	—
*	K032726	Zimmer M/L Taper Hip Prosthesis, 7711 Series Summary page 4 …prosthesis. PREDICATE DEVICES:  Biomet Taperloc® Complete (K101086, K103755)  Zimmer® M/L Taper Hip Prosthesis (K032726)  Biomet Taperloc® Complete Size 4mm and XR 123° (K120030)  Biomet Taperloc® Complete Microplasty S…	Zimmer, Inc.	2003	3
*	K120030	Taperloc Complete Size 4MM and XR 123 Summary page 4 …Biomet Taperloc® Complete (K101086, K103755)  Zimmer® M/L Taper Hip Prosthesis (K032726)  Biomet Taperloc® Complete Size 4mm and XR 123° (K120030)  Biomet Taperloc® Complete Microplasty System (K110400)  Zimmer Continuum™ and Trilogy® Integrated…	Biomet Manufacturing Corp	2012	—
*	K110400	Taperloc Complete Microplasty Stem Summary page 4 …M/L Taper Hip Prosthesis (K032726)  Biomet Taperloc® Complete Size 4mm and XR 123° (K120030)  Biomet Taperloc® Complete Microplasty System (K110400)  Zimmer Continuum™ and Trilogy® Integrated Taper (IT) Acetabular Systems (K091508) …	Biomet Manufacturing Corp	2011	—
*	K091508	Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System Summary page 4 … Biomet Taperloc® Complete Microplasty System (K110400)  Zimmer Continuum™ and Trilogy® Integrated Taper (IT) Acetabular Systems (K091508)  Aesculap Excia Total Hip System - Plasmacup SC (K042344) and Plasmacup NSC (K061699) …	Zimmer, Inc.	2009	3
*	K042344	Excia Total Hip System Summary page 4 … Zimmer Continuum™ and Trilogy® Integrated Taper (IT) Acetabular Systems (K091508)  Aesculap Excia Total Hip System - Plasmacup SC (K042344) and Plasmacup NSC (K061699)  Theken Companies iNSitu Total Hip System (K161184)  Sm…	Aesculap, Inc.	2005	10
*	K061699	EXCIA Summary page 4 …egrated Taper (IT) Acetabular Systems (K091508)  Aesculap Excia Total Hip System - Plasmacup SC (K042344) and Plasmacup NSC (K061699)  Theken Companies iNSitu Total Hip System (K161184)  Smith & Nephew REFLECTION ACETABULAR COMPONEN…	Aesculap, Inc.	2006	—
*	K161184	iNSitu Total Hip System Summary page 4 … Aesculap Excia Total Hip System - Plasmacup SC (K042344) and Plasmacup NSC (K061699)  Theken Companies iNSitu Total Hip System (K161184)  Smith & Nephew REFLECTION ACETABULAR COMPONENT (K932755, K022556)  Zimmer BIOLOX® Delta Ceramic F…	Theken Companies, LLC	2016	—
*	K932755	Reflection Acetabular Component Summary page 4 …Plasmacup NSC (K061699)  Theken Companies iNSitu Total Hip System (K161184)  Smith & Nephew REFLECTION ACETABULAR COMPONENT (K932755, K022556)  Zimmer BIOLOX® Delta Ceramic Femoral Head (K071535, K130899)  Zimmer VerSys® Fiber Hip P…	Smith & Nephew Richards, Inc.	1994	—
*	K022556	Reflection Modified Acetabular Shells Summary page 4 …NSC (K061699)  Theken Companies iNSitu Total Hip System (K161184)  Smith & Nephew REFLECTION ACETABULAR COMPONENT (K932755, K022556)  Zimmer BIOLOX® Delta Ceramic Femoral Head (K071535, K130899)  Zimmer VerSys® Fiber Hip Prosthesis…	Smith & Nephew, Inc.	2002	—
*	K071535	Biolox Delta Ceramic Femoral Head Summary page 4 …u Total Hip System (K161184)  Smith & Nephew REFLECTION ACETABULAR COMPONENT (K932755, K022556)  Zimmer BIOLOX® Delta Ceramic Femoral Head (K071535, K130899)  Zimmer VerSys® Fiber Hip Prosthesis (K061786, K964769)  Total Joint Orthopedics Klassic…	Zimmer, Inc.	2007	3
*	K130899	Biolox Delta Ceramic Femoral Heads Summary page 4 …ip System (K161184)  Smith & Nephew REFLECTION ACETABULAR COMPONENT (K932755, K022556)  Zimmer BIOLOX® Delta Ceramic Femoral Head (K071535, K130899)  Zimmer VerSys® Fiber Hip Prosthesis (K061786, K964769)  Total Joint Orthopedics Klassic HD Hip Sy…	Zimmer GmbH	2013	—
*	K061786	Versys Fiber Metal Midcoat Low Head Center Hip Prosthesis Summary page 4 …ACETABULAR COMPONENT (K932755, K022556)  Zimmer BIOLOX® Delta Ceramic Femoral Head (K071535, K130899)  Zimmer VerSys® Fiber Hip Prosthesis (K061786, K964769)  Total Joint Orthopedics Klassic HD Hip System (K143407)…	Zimmer, Inc.	2006	—
*	K964769	Versys Hip System--Fiber Metal Taper Hip Prosthesis Summary page 4 …R COMPONENT (K932755, K022556)  Zimmer BIOLOX® Delta Ceramic Femoral Head (K071535, K130899)  Zimmer VerSys® Fiber Hip Prosthesis (K061786, K964769)  Total Joint Orthopedics Klassic HD Hip System (K143407)…	Zimmer, Inc.	1997	—
*	K143407	Klassic HD Hip System Summary page 4 …mic Femoral Head (K071535, K130899)  Zimmer VerSys® Fiber Hip Prosthesis (K061786, K964769)  Total Joint Orthopedics Klassic HD Hip System (K143407) K163577…	Total Joint Othopedics, Inc.	2014	—

Also cleared against K101086: 8 other devices →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K180263	EcoFit Vit E Acetabular System	Implantcast GmbH	2018	5
K203420	EcoFit® Hip System	Implantcast GmbH	2021	4
K210678	implaFit® hip stems	Implantcast GmbH	2022	3
K240834	EcoFit® short stem cementless cpTi	Implantcast GmbH	2024	1
K223103	BethaLoc® stem cementless HA	Implantcast GmbH	2023	1
K252451	EPORE® XO cup system	Implantcast GmbH	2026	0
K260037	implantcast Packaging System Update	Implantcast GmbH	2026	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 10, 2021	Class II	Z-2050-2021	Device Design	A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or revision operation. A warning note is being added to instructions for use and…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
59 of the 285 ancestors have a recall of any class.
Of its descendants, K180263 (Implantcast GmbH, 2018) has gone furthest, with 5 descendants of its own.
8 other devices also cite its predicate K101086.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · LZO

14in 2025

2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007high 42 (2009) · low 0 (2010)2026

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

Adverse event reports per year · LZO

3,244in 2025

2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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	9	87	2	138
2008	11	63	13	125
2009	7	83	42	189
2010	15	78	0	394
2011	13	87	10	544
2012	14	98	14	963
2013	26	100	0	1,370
2014	13	85	1	1,477
2015	12	115	1	1,348
2016	10	177	9	1,728
2017	16	257	5	2,165
2018	18	163	2	3,133
2019	28	109	4	3,066
2020	18	112	3	1,963
2021	12	170	0	2,199
2022	11	279	4	1,985
2023	10	122	2	2,066
2024	11	111	1	2,586
2025	14	119	1	3,244
2026	9	102	0	—

What is it indicated for?

The EcoFit® Hip System is indicated for use as a total hip replacement in cases of:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

• Rheumatoid arthritis;

• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and

• Revision of previously failed total hip arthroplasty

The EcoFit® Hip Stem and EcoFit® Acetabular Cup are intended for uncemented, press-fit fixation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K163577 · printed Nov 5, 2026

Cite this page

510(k) Report. “K163577: Ecofit® Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163577

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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