510(k) · Cleared

Cleared

P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component

K945518510(k) TraditionalCleared Mar 8, 1996485-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

Johnson & Johnson Professionals, Inc. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Cleared on Mar 8, 1996 as substantially equivalent to K935452 (Johnson & Johnson Orthopaedics, Inc., 1994) after a 485-day review. Its family tree reaches back 1 generation to 1994. 212 later devices descend from it.

Decided: Mar 8, 1996
Review: 485 days
Class: Class II
Product code: KWY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K935452 (1994). 212 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
This deviceK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
Descendant · cites it directly · 210 of its ownK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
Descendant · cites it directly · 189 of its ownK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
Descendant · 2 generations on · 188 of its ownK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
Descendant · 3 generations on · 168 of its ownK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
Descendant · 4 generations on · 71 of its ownK082525 Corin Metafix Femoral StemCorin USA · 2010 · Recalled

Showing 5 of 212 descendants. See all descendants

Descendants cleared per year

1996high 20 (2023) · low 0 (1997)2026

Most influential descendants

Showing 5 of 212 · See all

K961939S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996 · cites it directly210descendants
K974331Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998 · cites it directly189descendants
K001991Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000 · 2 generations on188descendants
K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · 3 generations on168descendants
K082525Corin Metafix Femoral StemCorin USA · 2010 · 4 generations on71descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K935452	P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component	Johnson & Johnson Orthopaedics, Inc.	1994	—
0 (this device)	K945518	P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component	Johnson & Johnson Professionals, Inc.	1996	—
+1	K961939	S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)	Johnson & Johnson Professionals, Inc.	1996	—
+1	K974331	Uni-Rom Total Hip System Femoral Stem	Johnson & Johnson Professionals, Inc.	1998	—
+2	K001991	Titan Porocoat Hip Prosthesis	DePuy Orthopaedics, Inc.	2000	—
+3	K042992	Corail Amt Hip Prosthesis	DePuy Orthopaedics, Inc.	2005	1
+4	K082525	Corin Metafix Femoral Stem	Corin USA	2010	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	2	0
2000	2	0
2001	1	0
2004	4	0
2005	3	0
2006	1	0
2007	1	0
2008	3	0
2010	3	0
2011	5	0
2012	8	0
2013	12	0
2014	3	0
2015	6	0
2016	9	0
2017	13	0
2018	12	0
2019	14	0
2020	15	0
2021	9	0
2022	16	0
2023	20	0
2024	17	0
2025	18	0
2026	14	0

FIG. 1 — Lineage of K945518, 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 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
*	K935452	P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component Summary page 1 …lent and identical in function to the P F.C. 2 Total Hip System Porous Coated Modular Femoral Component cleared for commercial distribution under premarket notification #K935452. 5. INDICATIONS FOR USE The P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component is indicated for use in total and…	Johnson & Johnson Orthopaedics, Inc.	1994	—

Also cleared against K935452: 1 other device →

What descends from it? (212)

See all 212

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

Number	Device	Applicant	Decided	Descendants
K961939	S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)	Johnson & Johnson Professionals, Inc.	1996	210
K974331	Uni-Rom Total Hip System Femoral Stem	Johnson & Johnson Professionals, Inc.	1998	189
K982812	G2 Total Hip System Femoral Stem (11/13 Taper)	Johnson & Johnson Professionals, Inc.	1998	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 no recall.
Of its descendants, K961939 (Johnson & Johnson Professionals, Inc., 1996) has gone furthest, with 210 descendants of its own.
1 other device also cites its predicate K935452.

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 P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component is indicated for use in total and partial hip replacement procedures for patients suffering severe pain and disability due to structural damage tn the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and non-union of femoral fractures. Use of a prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion.

The P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component is indicated for use without bone cement (PMMA).

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/K945518 · printed Nov 6, 2026

Cite this page

510(k) Report. “K945518: P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945518

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