510(k) · Cleared

Cleared

E1 Antioxidant Infused Technology

K100048510(k) TraditionalCleared Mar 9, 201060-day reviewClass II21 CFR 888.3560

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

Biomet Manufacturing Corp · OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Cleared on Mar 9, 2010 as substantially equivalent to K080528 (Biomet Orthopedics, Inc., 2008) and 4 other predicates after a 60-day review. Its family tree reaches back 7 generations to 1981. 114 later devices descend from it.

Decided: Mar 9, 2010
Review: 60 days
Class: Class II
Product code: OIY
Recalls: None
Predicates: 5

Its longest line of descent runs back 7 generations to K810258 (1981). 33 ancestors in all. 114 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 7 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
6 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
5 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
4 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
3 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
2 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
1 generation backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
This deviceK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
Descendant · cites it directly · 88 of its ownK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
Descendant · cites it directly · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
Descendant · cites it directly · 24 of its ownK101336 E1 Avantage HeadBiomet Manufacturing Corp · 2011 · Recalled
Descendant · 2 generations on · 22 of its ownK110555 Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · Recalled
Descendant · 2 generations on · 21 of its ownK150522 G7 Dual Mobility SystemBiomet, Inc. · 2015 · Recalled

Showing 5 of 114 descendants. See all descendants

Descendants cleared per year

2011high 16 (2024) · low 1 (2017)2026

Most influential descendants

Showing 5 of 114 · See all

K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012 · cites it directly88descendants
K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · cites it directly59descendants
K101336E1 Avantage HeadBiomet Manufacturing Corp · 2011 · cites it directly24descendants
K110555Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · 2 generations on22descendants
K150522G7 Dual Mobility SystemBiomet, Inc. · 2015 · 2 generations on21descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K810258	Proximal Fermoral Hip Replacement	Biomet, Inc.	1981	—
−6	K974558	Salvage/Onocology Hip and Total Femur System	Biomet, Inc.	1998	—
−5	K032396	Ringloc 36MM Line and Modular Femoral Heads	Biomet, Inc.	2003	3
−4	K042051	Arcomxl Polyethylene Liners	Biomet, Inc.	2005	1
−3	K051411	Arcomxl Polyethylene Liners and Biolox Delta Heads	Biomet, Inc.	2005	1
−2	K061312	36MM Biolox Delta Ceramic Heads	Biomet, Inc.	2006	—
−1	K073102	Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners	Biomet Manufacturing Corp	2007	—
0 (this device)	K100048	E1 Antioxidant Infused Technology	Biomet Manufacturing Corp	2010	—
+1	K120370	Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners	Zimmer, Inc.	2012	—
+1	K121771	Zimmer Persona the Personalized Knee System	Zimmer, Inc.	2012	2
+1	K101336	E1 Avantage Head	Biomet Manufacturing Corp	2011	1
+2	K110555	Arcomxl Active Articulation	Biomet Manufacturing Corp	2011	2
+2	K150522	G7 Dual Mobility System	Biomet, Inc.	2015	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1992	3	0
1993	1	0
1994	4	0
1995	4	0
1997	1	0
2002	2	0
2003	2	0
2004	1	0
2005	3	0
2007	2	0
2008	1	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2012	4	0
2013	2	0
2014	2	0
2015	3	0
2016	4	0
2017	1	0
2018	6	0
2019	13	0
2020	9	0
2021	10	0
2022	8	0
2023	7	0
2024	16	0
2025	14	0
2026	13	0

FIG. 1 — Lineage of K100048, 1981–2026Source: 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 OIY? 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 OIY device

#1 K252887 DePuy ATTUNE™ Knee Systemscore 12.6 · 5 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? (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
*	K080528	E-Poly Tibial Bearings Summary page 1 …or non-porous, uncemented (888.3353) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The predicate devices are the E-PolyTM Tibial Bearings, K080528, cleared June 17, 2008; E-PolyTM MaxRomnTm Acetabular Liners, K070364, cleared May 3, 2007;…	Biomet Orthopedics, Inc.	2008	—
*	K070364	100KGY E-Poly Maxrom Acetabular Liners Summary page 1 …o Which Substantial Equivalence Is Claimed: The predicate devices are the E-PolyTM Tibial Bearings, K080528, cleared June 17, 2008; E-PolyTM MaxRomnTm Acetabular Liners, K070364, cleared May 3, 2007; r~~~- 510(k) Summary EI' m Antioxidant Infused Techno…	Biomet, Inc.	2007	—
*	K070399	100KGY E-Poly Acetabular Liners-Additional Profiles Summary page 2 …r~~~- 510(k) Summary EI' m Antioxidant Infused Technology Biomet Manufacturing Corp. Page 2 Profiles, K070399, cleared May 4, E-Poly TM (lO0kGy) Acetabular Liners-Additional 2007; Biolox®~ delta Ceramic Heads with 100 kGy E-PolyTm Acetabul…	Biomet Manufacturing, Inc.	2007	—
*	K073102	Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners Summary page 2 …Profiles, K070399, cleared May 4, E-Poly TM (lO0kGy) Acetabular Liners-Additional 2007; Biolox®~ delta Ceramic Heads with 100 kGy E-PolyTm Acetabular Liners, K073102, cleared November 27, 2007; and lOOkGy Acetabular Uiners Additional T and +3 Hi-Wall, K090103, cleared February…	Biomet Manufacturing Corp	2007	—
*	K090103	100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 HI-Wall Summary page 2 …ta Ceramic Heads with 100 kGy E-PolyTm Acetabular Liners, K073102, cleared November 27, 2007; and lOOkGy Acetabular Uiners Additional T and +3 Hi-Wall, K090103, cleared February 11, 2009. Profiles: +3 MaxRoMm Device Description: The device descriptions of the ElJTm Tibial Bearings and the…	Biomet, Inc.	2009	—

Also cleared against K080528: 5 other devices →

What descends from it? (114)

See all 114

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

Number	Device	Applicant	Decided	Descendants
K120370	Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners	Zimmer, Inc.	2012	88
K121771	Zimmer Persona the Personalized Knee System	Zimmer, Inc.	2012	59
K101336	E1 Avantage Head	Biomet Manufacturing Corp	2011	24
K122529	Zimmer Unicompartmental Knee System Vivacit-E Articular Surface	Zimmer, Inc.	2012	15
K120038	A200 Knee System	Renovis Surgical Technologies, LLC	2013	2

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 29 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
10 of the 33 ancestors have a recall of any class.
Of its descendants, K120370 (Zimmer, Inc., 2012) has gone furthest, with 88 descendants of its own.
5 other devices also cite its predicate K080528.

How does its category compare?

All OIY devices

OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · OIY

1in 2024

2007high 4 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OIY

132in 2010

2007high 132 (2010)2026

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

Recalls per year · OIY

1in 2015

2007high 1 (2014) · low 0 (2007)2026

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

Adverse event reports per year · OIY

35in 2025

2007high 379 (2021) · low 0 (2007)2025

MAUDE reports naming product code OIY, 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	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	4	132	0	0
2011	2	—	0	0
2012	2	—	0	6
2013	1	—	0	16
2014	0	—	1	84
2015	0	—	1	282
2016	0	—	0	130
2017	0	—	0	91
2018	0	—	0	68
2019	0	—	0	78
2020	1	—	0	121
2021	0	—	0	379
2022	0	—	0	42
2023	0	—	0	40
2024	1	—	0	34
2025	0	—	0	35
2026	1	—	0	—

What is it indicated for?

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. Cemented and Uncemented Applications (as based on mating shell) 1. Painful and…

Read the full statement (104 words)

1. Non-inflammatory degenerative joint disease including osteoarthritis and

avascular necrosis.

2. Rheumatoid arthritis.

3. Correction of functional deformity.

4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of

the proximal femur with head involvement, unmanageable using other

techniques.

5. Revision of previously failed total hip arthroplasty.

Cemented and Uncemented Applications (as based on mating shell)

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis,

traumatic arthritis where one or more compartments are involved.

2. Correction of varus, valgus, or posttraumatic deformity.

3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of

previous joint replacement procedure.

For cemented and un-cemented use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K100048 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100048: E1 Antioxidant Infused Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100048

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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