510(k) · Cleared

Cleared

Bencox ID Stem, Bencox Metal Head, Bencox Bipolar Cup

K112019510(k) TraditionalCleared Oct 12, 201190-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

Corentec Co., Ltd. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Cleared on Oct 12, 2011 as substantially equivalent to K043537 (Biomet, Inc., 2005) and 7 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1997. 10 later devices descend from it.

Decided: Oct 12, 2011
Review: 90 days
Class: Class II
Product code: KWY
Recalls: None
Predicates: 8

Its longest line of descent runs back 4 generations to P960047 (1997). 34 ancestors in all, the oldest K800207 (1980). 10 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 4 generations backP960047 Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp. · 1997
3 generations backK021728 Ringloc Constrained Liners IIBiomet, Inc. · 2002
2 generations backK030047 Freedom Constrained LinersBiomet, Inc. · 2003
1 generation backK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
This deviceK112019 Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd. · 2011
Descendant · cites it directly · 8 of its ownK121665 Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012
Descendant · cites it directly · 7 of its ownK150007 Modified Bencox Hip SystemCorentec Co., Ltd. · 2015
Descendant · 2 generations on · 6 of its ownK162127 Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · Recalled
Descendant · 2 generations on · 4 of its ownK172806 Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017
Descendant · 3 generations on · 3 of its ownK182221 Bencox Mirabo Cup Multi HoleCorentec Co., Ltd. · 2019

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2012high 2 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 10 · See all

K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012 · cites it directly8descendants
K150007Modified Bencox Hip SystemCorentec Co., Ltd. · 2015 · cites it directly7descendants
K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · 2 generations on6descendants
K172806Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017 · 2 generations on4descendants
K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd. · 2019 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	P960047	Osteonics Constrained Acetabular Insert	Howmedica Osteonics Corp.	1997	—
−3	K021728	Ringloc Constrained Liners II	Biomet, Inc.	2002	—
−2	K030047	Freedom Constrained Liners	Biomet, Inc.	2003	—
−1	K043537	Taperloc 12/14 Taper Femoral Components	Biomet, Inc.	2005	—
0 (this device)	K112019	Bencox ID Stem, Bencox Metal Head, Bencox Bipolar Cup	Corentec Co., Ltd.	2011	—
+1	K121665	Bencox Foret & Bencox Delta	Corentec Co., Ltd.	2012	—
+1	K150007	Modified Bencox Hip System	Corentec Co., Ltd.	2015	—
+2	K162127	Bencox M Stem Lateralized & Bencox Mirabo Cup System	Corentec Co., Ltd.	2016	1
+2	K172806	Bencox Mirabo Cup System	Corentec Co., Ltd.	2017	—
+3	K182221	Bencox Mirabo Cup Multi Hole	Corentec Co., Ltd.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1980	1	0
1983	2	0
1985	1	0
1986	1	0
1994	6	0
1995	1	0
1996	3	0
1997	3	0
1998	1	0
1999	3	0
2000	4	0
2001	2	0
2003	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	2	0
2015	1	0
2016	1	0
2017	1	0
2019	1	0
2021	1	0
2022	2	0
2023	1	0

FIG. 1 — Lineage of K112019, 1997–2023Source: 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? (8)

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
*	K043537	Taperloc 12/14 Taper Femoral Components Summary page 3 …5 .3 0 f 9 O 510(k) Premarket Notification BENCOX Bipolar Cup System Biomet. Inc., Taperloc® 12/14 Taper Femoral Components cleared under K043537; Biomet. Inc., Malloy Head® Lateralized Press-Fit Femoral cleared under K003429; Corin Group Ltd., Tni-Fit® Femoral Stem cleared…	Biomet, Inc.	2005	—
*	K003429	Malloy/Head Lateralized Press-Fit Femoral Summary page 3 …ipolar Cup System Biomet. Inc., Taperloc® 12/14 Taper Femoral Components cleared under K043537; Biomet. Inc., Malloy Head® Lateralized Press-Fit Femoral cleared under K003429; Corin Group Ltd., Tni-Fit® Femoral Stem cleared under K010243; Biomet. Inc., Metal On Metal Acetabular System cleared under K993…	Biomet, Inc.	2000	1
*	K010243	Tri-Fit Femoral Stem Summary page 3 …l Components cleared under K043537; Biomet. Inc., Malloy Head® Lateralized Press-Fit Femoral cleared under K003429; Corin Group Ltd., Tni-Fit® Femoral Stem cleared under K010243; Biomet. Inc., Metal On Metal Acetabular System cleared under K993438; Biomet, Inc., M2 a@32mm Taper System cleared under K003363…	Corin USA	2001	—
*	K993438	Metal on Metal Acetabular System Summary page 3 …ized Press-Fit Femoral cleared under K003429; Corin Group Ltd., Tni-Fit® Femoral Stem cleared under K010243; Biomet. Inc., Metal On Metal Acetabular System cleared under K993438; Biomet, Inc., M2 a@32mm Taper System cleared under K003363; StelKast Inc., Stelkast Bipolar Head cleared under K972961; Biomet,…	Biomet, Inc.	2000	—
*	K003363	M2A 32MM Taper System Summary page 3 …d., Tni-Fit® Femoral Stem cleared under K010243; Biomet. Inc., Metal On Metal Acetabular System cleared under K993438; Biomet, Inc., M2 a@32mm Taper System cleared under K003363; StelKast Inc., Stelkast Bipolar Head cleared under K972961; Biomet, Inc., RingLoc®&Bi-Polar Acetabular Component cleared under K…	Biomet, Inc.	2000	—
*	K972961	Stelkast Bipolar System Summary page 3 …., Metal On Metal Acetabular System cleared under K993438; Biomet, Inc., M2 a@32mm Taper System cleared under K003363; StelKast Inc., Stelkast Bipolar Head cleared under K972961; Biomet, Inc., RingLoc®&Bi-Polar Acetabular Component cleared under K05 1569; Stryker (Osteonics Corp.), UHR Universal hip Replac…	Stelkast Company	1997	—
*	K051569	Ringloc BI-Polar Acetabular Component Summary page 3 …a@32mm Taper System cleared under K003363; StelKast Inc., Stelkast Bipolar Head cleared under K972961; Biomet, Inc., RingLoc®&Bi-Polar Acetabular Component cleared under K05 1569; Stryker (Osteonics Corp.), UHR Universal hip Replacement cleared under K800207; The Bencox Bipolar Cup System's Bencox…	Biomet, Inc.	2005	4
*	K800207	Uhr UNIVERSAL6HIP Replacement Summary page 3 …leared under K972961; Biomet, Inc., RingLoc®&Bi-Polar Acetabular Component cleared under K05 1569; Stryker (Osteonics Corp.), UHR Universal hip Replacement cleared under K800207; The Bencox Bipolar Cup System's Bencox ID Stem and the Taperloc Stem (K043537), Mallory Head (K003429) and the TriFit (…	Osteonics Corp.	1980	36

Also cleared against K043537: 19 other devices →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K121665	Bencox Foret & Bencox Delta	Corentec Co., Ltd.	2012	8
K150007	Modified Bencox Hip System	Corentec Co., Ltd.	2015	7
K122099	Bencox II Stem, Bencox Metal Head	Corentec Co., Ltd.	2012	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 3 companies; a new generation was cleared every 5.4 years on median.
5 of the 34 ancestors have a recall of any class.
Of its descendants, K121665 (Corentec Co., Ltd., 2012) has gone furthest, with 8 descendants of its own.
19 other devices also cite its predicate K043537.

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. 2011, this device’s year, is highlighted.

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 Bencox Bipolar Cup system is intended for cementless use in partial or total hip arthroplasty in primary or revision surgery for the following conditions:

a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis;

b. Inflammatory degenerative joint disease, such as rheumatoid arthritis;

c. Treatment of non-union, femoral neck fracture and trochantric fractures of the proximal femur with head involvement, unmanageable using other techniques;

d. Patients with failed previous surgery where pain, deformity, or dysfunction persists;

e. Revision of previously failed hip arthroplasty.

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/K112019 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112019: Bencox ID Stem, Bencox Metal Head, Bencox Bipolar Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112019

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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