510(k) · Cleared

Cleared

Full Hemisphere Ring-Loc Liner

K920640510(k) TraditionalCleared Jun 30, 1992139-day reviewClass II21 CFR 888.3350

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

Biomet, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Jun 30, 1992 after a 139-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 493 later devices descend from it.

Decided: Jun 30, 1992
Review: 139 days
Class: Class II
Product code: JDI
Recalls: None
Predicates: 0

493 later devices descend from it, 2 citing it directly.

This deviceK920640 Full Hemisphere Ring-Loc LinerBiomet, Inc. · 1992
Descendant · cites it directly · 480 of its ownK023357 Arcpm 1050 Resin-HipsBiomet Orthopedics, Inc. · 2002 · Recalled
Descendant · 2 generations on · 355 of its ownK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
Descendant · 3 generations on · 344 of its ownK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
Descendant · 4 generations on · 343 of its ownK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
Descendant · 2 generations on · 289 of its ownK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005

Showing 5 of 493 descendants. See all descendants

Descendants cleared per year

2002high 38 (2025) · low 0 (2003)2026

Most influential descendants

Showing 5 of 493 · See all

K023357Arcpm 1050 Resin-HipsBiomet Orthopedics, Inc. · 2002 · cites it directly480descendants
K042051Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · 2 generations on355descendants
K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · 3 generations on344descendants
K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006 · 4 generations on343descendants
K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005 · 2 generations on289descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K920640	Full Hemisphere Ring-Loc Liner	Biomet, Inc.	1992	—
+1	K023357	Arcpm 1050 Resin-Hips	Biomet Orthopedics, Inc.	2002	1
+2	K042051	Arcomxl Polyethylene Liners	Biomet, Inc.	2005	1
+3	K051411	Arcomxl Polyethylene Liners and Biolox Delta Heads	Biomet, Inc.	2005	1
+4	K061312	36MM Biolox Delta Ceramic Heads	Biomet, Inc.	2006	—
+2	K050327	E-Poly (Vitamin E) Acetabular Liners	Biomet, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2005	6	0
2006	2	0
2007	5	0
2008	3	0
2009	6	0
2010	7	0
2011	12	0
2012	20	0
2013	33	0
2014	29	0
2015	23	0
2016	26	0
2017	22	0
2018	26	0
2019	36	0
2020	33	0
2021	31	0
2022	34	0
2023	32	0
2024	34	0
2025	38	0
2026	34	0

FIG. 1 — Lineage of K920640, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JDI? 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 JDI device

#1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (493)

See all 493

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

Number	Device	Applicant	Decided	Descendants
K023357	Arcpm 1050 Resin-Hips	Biomet Orthopedics, Inc.	2002	480
K050124	Porous Coated Acetabular Components	Biomet, Inc.	2005	138

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?

Of its descendants, K023357 (Biomet Orthopedics, Inc., 2002) has gone furthest, with 480 descendants of its own.

How does its category compare?

All JDI devices

JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDI

1in 2025

2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007high 247 (2020) · low 59 (2024)2026

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

Recalls per year · JDI

1in 2025

2007high 77 (2020) · low 0 (2021)2026

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

Adverse event reports per year · JDI

1,644in 2025

2007high 7,407 (2019) · low 696 (2007)2025

MAUDE reports naming product code JDI, 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	3	81	26	696
2008	5	96	6	810
2009	3	65	3	964
2010	0	—	3	2,040
2011	2	—	5	3,160
2012	4	167	4	5,122
2013	3	176	11	5,206
2014	3	98	3	4,968
2015	3	190	1	4,906
2016	4	166	5	3,995
2017	1	—	5	6,135
2018	1	—	1	6,728
2019	2	—	1	7,407
2020	7	247	77	4,015
2021	3	162	0	3,170
2022	3	69	0	1,978
2023	2	—	0	1,635
2024	3	59	0	1,821
2025	1	—	1	1,644
2026	2	—	0	—

https://510kreport.com/device/K920640 · printed Nov 6, 2026

Cite this page

510(k) Report. “K920640: Full Hemisphere Ring-Loc Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920640

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026