510(k) · Cleared

Cleared

Plus Bipolar Prosthesis Cocrmo

K982447510(k) TraditionalCleared Nov 25, 1998133-day reviewClass II21 CFR 888.3390

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

Plus Orthopedics · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Cleared on Nov 25, 1998 as substantially equivalent to K953510 (Encore Orthopedics, Inc., 1995) after a 133-day review. Its family tree reaches back 1 generation to 1995. 36 later devices descend from it.

Decided: Nov 25, 1998
Review: 133 days
Class: Class II
Product code: KWY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K953510 (1995). 36 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK953510 Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented…Encore Orthopedics, Inc. · 1995 · Recalled
This deviceK982447 Plus Bipolar Prosthesis CocrmoPlus Orthopedics · 1998
Descendant · cites it directly · 21 of its ownK082468 Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in…Omni Life Science, Inc. · 2009 · Recalled
Descendant · cites it directly · 11 of its ownK060707 Aesculap Bipolar Acetabular CupAesculap, Inc. · 2006
Descendant · cites it directly · 9 of its ownK091967 Medacta Bipolar HeadMedacta International S.A. · 2010
Descendant · cites it directly · 7 of its ownK082705 Biopro Bipolar Head, Models 18130-18152Biopro, Inc. · 2008
Descendant · 2 generations on · 5 of its ownK133370 Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve…Signature Orthopaedics Pty Limited · 2014

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2006high 4 (2026) · low 0 (2007)2026

Most influential descendants

Showing 5 of 36 · See all

K082468Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM] (38-43), YY=OD…Omni Life Science, Inc. · 2009 · cites it directly21descendants
K060707Aesculap Bipolar Acetabular CupAesculap, Inc. · 2006 · cites it directly11descendants
K091967Medacta Bipolar HeadMedacta International S.A. · 2010 · cites it directly9descendants
K082705Biopro Bipolar Head, Models 18130-18152Biopro, Inc. · 2008 · cites it directly7descendants
K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited · 2014 · 2 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K953510	Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented Prosthesis	Encore Orthopedics, Inc.	1995	18
0 (this device)	K982447	Plus Bipolar Prosthesis Cocrmo	Plus Orthopedics	1998	—
+1	K082468	Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM]…	Omni Life Science, Inc.	2009	23
+1	K060707	Aesculap Bipolar Acetabular Cup	Aesculap, Inc.	2006	—
+1	K091967	Medacta Bipolar Head	Medacta International S.A.	2010	—
+1	K082705	Biopro Bipolar Head, Models 18130-18152	Biopro, Inc.	2008	—
+2	K133370	Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip…	Signature Orthopaedics Pty Limited	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0
2009	1	0
2010	3	0
2013	2	0
2014	2	0
2015	2	0
2016	1	0
2017	2	0
2018	1	0
2019	3	0
2020	3	0
2021	2	0
2022	2	0
2023	1	0
2024	2	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K982447, 1995–2026Source: 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 KWY? 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 KWY device

#1 K253357 b-ONE® Bipolar Headscore 11.2 · 1 generation · 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? (1)

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
*	K953510	Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented Prosthesis Summary page 1 …thesis Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (87KWY) Foundation Hip System, Bipolar Assembly, Encore Orthopedics, Austin, Texas (K953510). The PLUS Bipolar Prosthesis CoCrMo is a one-piece hip joint prosthesis comprised of a CoCrMo shell, a polyethylene insert and…	Encore Orthopedics, Inc.	1995	18

Also cleared against K953510: 2 other devices →

What descends from it? (36)

See all 36

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

Number	Device	Applicant	Decided	Descendants
K082468	Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM] (38-43), YY=OD…	Omni Life Science, Inc.	2009	21
K060707	Aesculap Bipolar Acetabular Cup	Aesculap, Inc.	2006	11
K091967	Medacta Bipolar Head	Medacta International S.A.	2010	9
K082705	Biopro Bipolar Head, Models 18130-18152	Biopro, Inc.	2008	7
K123598	Smith & Nephew, Inc. Hip System Instrumentation	Smith & Nephew, Inc.	2013	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?

Its one ancestor has a recall.
Of its descendants, K082468 (Omni Life Science, Inc., 2009) has gone furthest, with 21 descendants of its own.
2 other devices also cite its predicate K953510.

How does its category compare?

All KWY devices

KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWY

1in 2025

2007high 5 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWY

126in 2019

2007high 219 (2018) · low 123 (2008)2026

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

Recalls per year · KWY

2in 2025

2007high 25 (2007) · low 0 (2008)2026

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

Adverse event reports per year · KWY

180in 2025

2007high 1,530 (2019) · low 178 (2023)2025

MAUDE reports naming product code KWY, 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	—	25	370
2008	3	123	0	900
2009	1	—	24	961
2010	4	187	1	688
2011	1	—	0	758
2012	1	—	1	978
2013	2	—	2	1,148
2014	1	—	0	1,055
2015	1	—	0	1,213
2016	1	—	3	877
2017	1	—	2	826
2018	3	219	1	1,380
2019	5	126	1	1,530
2020	1	—	0	1,259
2021	0	—	0	276
2022	2	—	0	208
2023	2	—	0	178
2024	0	—	1	209
2025	1	—	2	180
2026	1	—	0	—

What is it indicated for?

The Plus Bipolar Prosthesis CoCrMo in intended for use in arthroplasty therapy as a result of femoral neck fractures and is to be used in conjunction with standard femoral replacement implant. This device is intended for Cementless use only.

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/K982447 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982447: Plus Bipolar Prosthesis Cocrmo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982447

Report an extraction error

Are you the manufacturer?

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