510(k) · Cleared

Cleared

Biolox Delta Ceramic Femoral Head

K082991510(k) SpecialCleared Nov 20, 200844-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

Aesculap Implant Systems, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Nov 20, 2008 as substantially equivalent to K042344 (Aesculap, Inc., 2005) and 4 other predicates after a 44-day review. Its family tree reaches back 8 generations to 1994. 63 later devices descend from it.

Decided: Nov 20, 2008
Review: 44 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 5

Its longest line of descent runs back 8 generations to K941847 (1994). 100 ancestors in all, the oldest K810258 (1981). 63 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 8 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
7 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
6 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
5 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
4 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
3 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
2 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
1 generation backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
This deviceK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
Descendant · cites it directly · 59 of its ownK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
Descendant · 2 generations on · 58 of its ownK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
Descendant · 3 generations on · 53 of its ownK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
Descendant · 3 generations on · 52 of its ownK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
Descendant · 4 generations on · 48 of its ownK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled

Showing 5 of 63 descendants. See all descendants

Descendants cleared per year

2009high 10 (2025) · low 1 (2010)2026

Most influential descendants

Showing 5 of 63 · See all

K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009 · cites it directly59descendants
K090845Apex Arc Hip StemOmni Life Science, Inc. · 2010 · 2 generations on58descendants
K111193Apex Arc Hip StemOmni Life Science, Inc. · 2011 · 3 generations on53descendants
K113242Apex Arc Hip StemOmni Life Science, Inc. · 2012 · 3 generations on52descendants
K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · 4 generations on48descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K941847	5/8 Porocoat Aml Hip Porocoat Porous Coating	Depuy, Inc.	1994	—
−7	K964650	TCP-Coated Porocoat Aml Femoral Hip Prosthesis	Depuy, Inc.	1997	—
−6	K980711	Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating	Zimmer, Inc.	1998	1
−5	K001277	Triflange Acetabular Cup System	DePuy Orthopaedics, Inc.	2000	—
−4	K031495	Pinnacle Duofix HA Acetabular Cup Prosthesis	DePuy Orthopaedics, Inc.	2003	—
−3	K042344	Excia Total Hip System	Aesculap, Inc.	2005	10
−2	K060918	Excia Total Hip System 12/14 Trunnion with Ceramic Head	Aesculap, Inc.	2006	—
−1	K062684	Excia Total Hip System 36MM Ceramic Head	Aesculap, Inc.	2006	—
0 (this device)	K082991	Biolox Delta Ceramic Femoral Head	Aesculap Implant Systems, Inc.	2008	—
+1	K083495	Modification to: Metha Hip System	Aesculap Implant Systems, Inc.	2009	—
+2	K090845	Apex Arc Hip Stem	Omni Life Science, Inc.	2010	2
+3	K111193	Apex Arc Hip Stem	Omni Life Science, Inc.	2011	—
+3	K113242	Apex Arc Hip Stem	Omni Life Science, Inc.	2012	—
+4	K123991	Depuy Corail Amt Hip Prosthesis	Depuy France S.A.S.	2013	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1984	1	0
1985	1	0
1987	2	0
1990	2	0
1991	3	0
1992	3	0
1993	2	0
1994	12	0
1995	12	0
1996	7	0
1997	6	0
1998	5	0
1999	2	0
2000	5	0
2001	3	0
2002	6	0
2003	6	0
2004	4	0
2005	3	0
2006	3	0
2007	1	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	2	0
2010	1	0
2011	4	0
2012	1	0
2013	1	0
2014	1	0
2015	2	0
2016	1	0
2017	4	0
2018	3	0
2019	2	0
2020	3	0
2021	4	0
2022	5	0
2023	6	0
2024	6	0
2025	10	0
2026	7	0

FIG. 1 — Lineage of K082991, 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

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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
*	K042344	Excia Total Hip System Summary page 1 …, KWY SUBSTANTIAL EQUIVALENCE Aesculap Implant Systems, Inc. believes that the BIOLOX® delta Ceramic Femoral Head is a line extension of Aesculap Implant Systems Excia (K042344, K06091 8, and K062684) - Hip Systems and Metha Short Stem Hip System (K080584) that were previously cleared. It is also substant…	Aesculap, Inc.	2005	10
*	K060918	Excia Total Hip System 12/14 Trunnion with Ceramic Head Summary page 1 …BSTANTIAL EQUIVALENCE Aesculap Implant Systems, Inc. believes that the BIOLOX® delta Ceramic Femoral Head is a line extension of Aesculap Implant Systems Excia (K042344, K06091 8, and K062684) - Hip Systems and Metha Short Stem Hip System (K080584) that were previously cleared. It is also substantially equi…	Aesculap, Inc.	2006	—
*	K062684	Excia Total Hip System 36MM Ceramic Head Summary page 1 …VALENCE Aesculap Implant Systems, Inc. believes that the BIOLOX® delta Ceramic Femoral Head is a line extension of Aesculap Implant Systems Excia (K042344, K06091 8, and K062684) - Hip Systems and Metha Short Stem Hip System (K080584) that were previously cleared. It is also substantially equivalent to the…	Aesculap, Inc.	2006	—
*	K080584	Metha Short Stem Hip System Summary page 1 …BIOLOX® delta Ceramic Femoral Head is a line extension of Aesculap Implant Systems Excia (K042344, K06091 8, and K062684) - Hip Systems and Metha Short Stem Hip System (K080584) that were previously cleared. It is also substantially equivalent to the Zimmer BIOLOX delta Ceramic Femoral Head (K071 535). D…	Aesculap Implant System, Inc.	2008	—
*	K071535	Biolox Delta Ceramic Femoral Head Summary page 1 …Hip Systems and Metha Short Stem Hip System (K080584) that were previously cleared. It is also substantially equivalent to the Zimmer BIOLOX delta Ceramic Femoral Head (K071 535). DEVICE DESCRIPTION The Aesculap Implant Systems BIOLOX® delta Ceramic Femoral Heads are manufactured from an alumina matrix co…	Zimmer, Inc.	2007	3

Also cleared against K042344: 16 other devices →

What descends from it? (63)

See all 63

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

Number	Device	Applicant	Decided	Descendants
K083495	Modification to: Metha Hip System	Aesculap Implant Systems, Inc.	2009	59
K090299	Biolox Option Ceramic Femoral Head and Metha XL Heads	Aesculap Implant Systems	2009	1
K172235	CoreHip® System	Aesculap Implants Systems, LLC	2018	0
K110542	Consensus Biolox Delta Ceramic Femoral Head	Consensus Orthopedics, Inc.	2011	0

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 14 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
28 of the 99 ancestors have a recall of any class.
Of its descendants, K083495 (Aesculap Implant Systems, Inc., 2009) has gone furthest, with 59 descendants of its own.
16 other devices also cite its predicate K042344.

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. 2008, 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 Excia Hip System is intended to replace a hip joint. The device is intended for: Patients suffering from severe hip 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. Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis Patients suffering from disability…

Read the full statement (198 words)

The Excia Hip System is intended to replace a hip joint.

The device is intended for:

Patients suffering from severe hip 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.

Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis

Patients suffering from disability due previous fusion

Patients with acute femoral neck fractures

The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without p-CaP®.

The Metha® Hip System (uncemented, press-fit fixation) is intended to replace a hip joint.

The device is intended for:

skeletally mature individuals undergoing primary surgery for total hip replacement

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.

patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis

patients suffering from disability due to previous fusion

patients with acute femoral neck fractures

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082991 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082991: Biolox Delta Ceramic Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082991

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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