510(k) · Cleared

Cleared

OMNI Anseris Hip Stem

K171156510(k) TraditionalCleared Aug 17, 2017119-day reviewClass II21 CFR 888.3353

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

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

Cleared on Aug 17, 2017 as substantially equivalent to K043123 (Apex Surgical, LLC, 2005) and 16 other predicates after a 119-day review. Its family tree reaches back 14 generations to 1994.

Decided: Aug 17, 2017
Review: 119 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 17

Its longest line of descent runs back 14 generations to K941847 (1994). 252 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.

By dateBy generation

Root · 14 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
10 generations between
3 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
2 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
1 generation backK133381 Omni Arc Monoblock Hip StemOmnilife Science · 2014
This deviceK171156 OMNI Anseris Hip StemOmnilife Science · 2017

Show all 14 generations

Root · 14 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
13 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
12 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
11 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
10 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
9 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
8 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
7 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
6 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
5 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
4 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
3 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
2 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
1 generation backK133381 Omni Arc Monoblock Hip StemOmnilife Science · 2014
This deviceK171156 OMNI Anseris Hip StemOmnilife Science · 2017

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−14	K941847	5/8 Porocoat Aml Hip Porocoat Porous Coating	Depuy, Inc.	1994	—
−13	K964650	TCP-Coated Porocoat Aml Femoral Hip Prosthesis	Depuy, Inc.	1997	—
−12	K980711	Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating	Zimmer, Inc.	1998	1
−11	K001277	Triflange Acetabular Cup System	DePuy Orthopaedics, Inc.	2000	—
−10	K031495	Pinnacle Duofix HA Acetabular Cup Prosthesis	DePuy Orthopaedics, Inc.	2003	—
−9	K042344	Excia Total Hip System	Aesculap, Inc.	2005	10
−8	K060918	Excia Total Hip System 12/14 Trunnion with Ceramic Head	Aesculap, Inc.	2006	—
−7	K062684	Excia Total Hip System 36MM Ceramic Head	Aesculap, Inc.	2006	—
−6	K082991	Biolox Delta Ceramic Femoral Head	Aesculap Implant Systems, Inc.	2008	—
−5	K083495	Modification to: Metha Hip System	Aesculap Implant Systems, Inc.	2009	—
−4	K090845	Apex Arc Hip Stem	Omni Life Science, Inc.	2010	2
−3	K111193	Apex Arc Hip Stem	Omni Life Science, Inc.	2011	—
−2	K113242	Apex Arc Hip Stem	Omni Life Science, Inc.	2012	—
−1	K133381	Omni Arc Monoblock Hip Stem	Omnilife Science	2014	—
0 (this device)	K171156	OMNI Anseris Hip Stem	Omnilife Science	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1983	3	0
1984	1	0
1985	3	0
1986	5	0
1987	3	0
1988	2	0
1990	3	0
1991	5	0
1992	7	0
1993	6	0
1994	31	0
1995	19	0
1996	21	0
1997	13	0
1998	11	0
1999	9	0
2000	16	0
2001	8	0
2002	12	0
2003	11	0
2004	6	0
2005	9	0
2006	7	0
2007	5	0
2008	4	0
2009	2	0
2010	7	0
2011	3	0
2012	1	0
2013	1	0
2015	1	0
2016	1	0

FIG. 1 — Lineage of K171156, 1994–2017Source: 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? (17)

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
*	K043123	Apex Modular HA Hip Stem Summary page 4 …r uncemented prosthesis. Product Code – LWJ Primary Predicate Device Apex Modular HA Stem K043123 Additional Predicate Devices Apex Modular Alumina Head, K012918 Apex hip System Bipol…	Apex Surgical, LLC	2005	—
*	K012918	Apex Modular Alumina Femoral Head Summary page 4 …– LWJ Primary Predicate Device Apex Modular HA Stem K043123 Additional Predicate Devices Apex Modular Alumina Head, K012918 Apex hip System Bipolar Head, K082468 Apex Hip System Bipol…	Apex Surgical, LLC	2001	—
*	K082468	Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM] (38-43), YY=OD… Summary page 4 …K043123 Additional Predicate Devices Apex Modular Alumina Head, K012918 Apex hip System Bipolar Head, K082468 Apex Hip System Bipolar Head, K100151 Apex Modular Head, +1…	Omni Life Science, Inc.	2009	23
*	K100151	Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44 to 60MM) Summary page 4 …x Modular Alumina Head, K012918 Apex hip System Bipolar Head, K082468 Apex Hip System Bipolar Head, K100151 Apex Modular Head, +10.5mm offset, K101575 Apex Modular Hip…	Omnlife Science	2010	—
*	K101575	Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810… Summary page 4 …stem Bipolar Head, K082468 Apex Hip System Bipolar Head, K100151 Apex Modular Head, +10.5mm offset, K101575 Apex Modular Hip System Biolox delta Femoral Head, K17…	Omnlife Science	2010	—
*	K101451	Apex Module Hip System Biolox Delta Femoral Head Summary page 5 …Apex Modular Hip System Biolox delta Femoral Head, K171156 Page 2 of 4 K101451 Interface Acetabular System, Acetabular Insert +4 offset, K092443…	Omni Life Science, Inc.	2010	—
*	K092443	Interface Acetabular Cup Liners Summary page 5 …Page 2 of 4 K101451 Interface Acetabular System, Acetabular Insert +4 offset, K092443 Omni Skirted Heads, K152919 Apex Modular Hip Stem, K000788…	Omni Life Science, Inc.	2009	—
*	K152919	OMNI Skirted Heads Summary page 5 …K101451 Interface Acetabular System, Acetabular Insert +4 offset, K092443 Omni Skirted Heads, K152919 Apex Modular Hip Stem, K000788 Apex Modular Acetabular Cup, K031110…	Omni Life Science, Inc.	2016	—
*	K000788	Apex Modular Hip Stem Summary page 5 …r System, Acetabular Insert +4 offset, K092443 Omni Skirted Heads, K152919 Apex Modular Hip Stem, K000788 Apex Modular Acetabular Cup, K031110 Apex Modular Acetabular Cup, K112779…	Apex Surgical, LLC	2000	—
*	K031110	Apex Modular Acetabular Cup Summary page 5 …, K092443 Omni Skirted Heads, K152919 Apex Modular Hip Stem, K000788 Apex Modular Acetabular Cup, K031110 Apex Modular Acetabular Cup, K112779 Apex HCLA Acetabular Cup Liners, K062489…	Apex Surgical, LLC	2003	—
*	K112779	Apex Modular Acctabular Cup (Now Named Apex Interface Acetabular System) Summary page 5 …Apex Modular Hip Stem, K000788 Apex Modular Acetabular Cup, K031110 Apex Modular Acetabular Cup, K112779 Apex HCLA Acetabular Cup Liners, K062489 Apex HCLA Acetabular Liners, K073150…	Omnlife Science	2011	1
*	K062489	Apex Hcla Acetabular Cup Liners Summary page 5 …Apex Modular Acetabular Cup, K031110 Apex Modular Acetabular Cup, K112779 Apex HCLA Acetabular Cup Liners, K062489 Apex HCLA Acetabular Liners, K073150 Biopro Bipolar Head, Models 18130-18152, K08…	Omnilife Science	2007	—
*	K073150	Apex-LNK Poly Acetabular Cup Liners Summary page 5 …Apex Modular Acetabular Cup, K112779 Apex HCLA Acetabular Cup Liners, K062489 Apex HCLA Acetabular Liners, K073150 Biopro Bipolar Head, Models 18130-18152, K082705 OMNI Interface Acetabular System…	Omni Life Science, Inc.	2008	—
*	K082705	Biopro Bipolar Head, Models 18130-18152 Summary page 5 …Apex HCLA Acetabular Cup Liners, K062489 Apex HCLA Acetabular Liners, K073150 Biopro Bipolar Head, Models 18130-18152, K082705 OMNI Interface Acetabular System, K142201 +4 Offset Acetabular Insert, K101976…	Biopro, Inc.	2008	—
*	K142201	OMNI Interface Acetabular System Summary page 5 …Apex HCLA Acetabular Liners, K073150 Biopro Bipolar Head, Models 18130-18152, K082705 OMNI Interface Acetabular System, K142201 +4 Offset Acetabular Insert, K101976 ARC Monoblock Hip Stem, K133381 Purpose of S…	Omnlife Science	2015	—
*	K101976	Interface Acetabular System, Acetabular Insert +4 Offset Summary page 5 …Biopro Bipolar Head, Models 18130-18152, K082705 OMNI Interface Acetabular System, K142201 +4 Offset Acetabular Insert, K101976 ARC Monoblock Hip Stem, K133381 Purpose of Submission This traditional 510(k) premarket notification is…	Omni Life Science, Inc.	2010	1
*	K133381	Omni Arc Monoblock Hip Stem Summary page 5 …OMNI Interface Acetabular System, K142201 +4 Offset Acetabular Insert, K101976 ARC Monoblock Hip Stem, K133381 Purpose of Submission This traditional 510(k) premarket notification is being submitted to obtain clear…	Omnilife Science	2014	—

Also cleared against K043123: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
50 of the 251 ancestors have a recall of any class.
2 other devices also cite its predicate K043123.

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 OMNI Anseris Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for hip arthroplasty to treat the following conditions…

Read the full statement (146 words)

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

* Rheumatoid arthritis;

* Correction of functional deformity;

* Congenital dislocation;

* Revision procedures where other treatments or devices have failed;

* Femoral neck and trochanteric fractures of the proximal femur.

The OMNI Anseris Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head. For further details, please refer to the Apex Bipolar Head Instructions for Use.

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/K171156 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171156: OMNI Anseris Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171156

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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