510(k) · Cleared

Cleared

S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)

K961939510(k) TraditionalCleared Aug 13, 199685-day reviewClass II21 CFR 888.3358

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. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Aug 13, 1996 as substantially equivalent to K851422 (Joint Medical Products Corp., 1985) and 6 other predicates after an 85-day review. Its family tree reaches back 2 generations to 1994. 210 later devices descend from it.

Decided: Aug 13, 1996
Review: 85 days
Class: Class II
Product code: LPH
Recalls: None
Predicates: 7

Its longest line of descent runs back 2 generations to K935452 (1994). 8 ancestors in all, the oldest K851422 (1985). 210 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 2 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
1 generation backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
This deviceK961939 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
Descendant · 5 generations on · 61 of its ownK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012

Showing 5 of 210 descendants. See all descendants

Descendants cleared per year

1998high 20 (2023) · low 0 (1999)2026

Most influential descendants

Showing 5 of 210 · See all

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
K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012 · 5 generations on61descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K935452	P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component	Johnson & Johnson Orthopaedics, Inc.	1994	—
−1	K945518	P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component	Johnson & Johnson Professionals, Inc.	1996	—
0 (this device)	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
+5	K120362	Metafix Femoral Stem for Hemi-Arthroplasty	Corin USA	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1991	1	0
1992	2	0
1994	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	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 K961939, 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 LPH? 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 LPH device

#1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 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? (7)

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
*	K851422	S-Rom 135 Femoral Stem & Collar (Part of S-Rom Hip Summary page 1 …) are substantially equivalent to several hip prostheses currently marketed in the United States for hip replacement including the S-ROM Femoral Hip Stems cleared under #K851422, #K913231, #K921111, #K934412, #K910664 and #K954935. The subject device is also substantially equivalent to hip prostheses such…	Joint Medical Products Corp.	1985	—
*	K913231	S-Rom (TM) Total Lhip System W/Ceramic Head Summary page 1 …tantially equivalent to several hip prostheses currently marketed in the United States for hip replacement including the S-ROM Femoral Hip Stems cleared under #K851422, #K913231, #K921111, #K934412, #K910664 and #K954935. The subject device is also substantially equivalent to hip prostheses such as the P.F…	Joint Medical Products Corp.	1991	—
*	K921111	S-Rom Zirconia Cermamic Femoral Head Summary page 1 …equivalent to several hip prostheses currently marketed in the United States for hip replacement including the S-ROM Femoral Hip Stems cleared under #K851422, #K913231, #K921111, #K934412, #K910664 and #K954935. The subject device is also substantially equivalent to hip prostheses such as the P.F.C.* Total…	Joint Medical Products Corp.	1992	—
*	K934412	Coated ZT Proximal Sleeve Summary page 1 …to several hip prostheses currently marketed in the United States for hip replacement including the S-ROM Femoral Hip Stems cleared under #K851422, #K913231, #K921111, #K934412, #K910664 and #K954935. The subject device is also substantially equivalent to hip prostheses such as the P.F.C.* Total Hip Syste…	Joint Medical Products Corp.	1994	—
*	K910664	Mod. Trochanter Screw & Washer W/ Anodized Titan. Summary page 1 …l hip prostheses currently marketed in the United States for hip replacement including the S-ROM Femoral Hip Stems cleared under #K851422, #K913231, #K921111, #K934412, #K910664 and #K954935. The subject device is also substantially equivalent to hip prostheses such as the P.F.C.* Total Hip System (#K94451…	Medimix Products, Inc.	1992	—
*	K954935	S-Rom Femoral Hip Stem - Size 14 X 8 Summary page 1 …ses currently marketed in the United States for hip replacement including the S-ROM Femoral Hip Stems cleared under #K851422, #K913231, #K921111, #K934412, #K910664 and #K954935. The subject device is also substantially equivalent to hip prostheses such as the P.F.C.* Total Hip System (#K944518). 6003018…	Joint Medical Products Corp.	1996	—
*	K945518	P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component Our OCR of the scanned summary read K944518, FDA’s number for Widex Model Logo 8S (Widex Hearing Aid Co., Inc.). Corrected to the only number one digit away that is an earlier device of this one’s maker, Johnson & Johnson Professionals, Inc., in this field.	Johnson & Johnson Professionals, Inc.	1996	—

Also cleared against K851422: 8 other devices →

What descends from it? (210)

See all 210

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

Number	Device	Applicant	Decided	Descendants
K974331	Uni-Rom Total Hip System Femoral Stem	Johnson & Johnson Professionals, Inc.	1998	189
K070554	Depuy Corail Amt Dysplasia Hip Prosthesis	DePuy Orthopaedics, Inc.	2007	49
K042127	Smith & Nephew Modular Hip	Smith & Nephew, Inc.	2004	17
K052426	Smith & Nephew Modular Hip	Smith & Nephew, Inc.	2005	6
K231873	DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…	Depuy Ireland UC	2024	5
K162303	REDAPT Sleeved Monolithic Revision Stems	Smith & Nephew, Inc.	2017	4
K061221	Dupuy S-Rom STD Hip Stem Prosthesis	DePuy Orthopaedics, Inc.	2006	0
K032730	Fixion Hip System	Disc-O-Tech Medical Technologies, Ltd.	2004	0
K992403	MRP-Titan	Rotec Medizintechnik GmbH	2000	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 2 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
None of the 8 ancestors has a recall.
Of its descendants, K974331 (Johnson & Johnson Professionals, Inc., 1998) has gone furthest, with 189 descendants of its own.
8 other devices also cite its predicate K851422.

How does its category compare?

All LPH devices

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

FDA decisions per year · LPH

12in 2025

2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007high 410 (2021) · low 76 (2012)2026

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

Recalls per year · LPH

4in 2025

2007high 30 (2012) · low 1 (2008)2026

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

Adverse event reports per year · LPH

6,163in 2025

2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, 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	10	116	16	509
2008	10	86	1	706
2009	3	112	2	1,156
2010	15	100	22	2,007
2011	16	110	26	3,320
2012	25	76	30	3,785
2013	11	135	9	5,002
2014	20	129	3	5,163
2015	18	111	1	5,830
2016	10	150	8	4,900
2017	12	121	14	5,312
2018	9	145	2	5,954
2019	22	164	8	7,130
2020	7	164	6	5,429
2021	8	410	4	5,978
2022	14	247	2	5,223
2023	10	111	2	5,345
2024	6	92	1	5,626
2025	12	153	4	6,163
2026	8	256	2	—

What is it indicated for?

The S-ROM Femoral Hip Stem - Sizes 12 x 06 x 115 and 12 x 07 x 115 is intended for non-cemented fixation as the femoral component of a total hip replacement system. The stems are indicated for use in primary and revision replacement surgery. The prosthesis may be used for the following conditions, as appropriate:

. Osteoarthritis;

. Traumatic Fractures;

o. Rheumatoid Arthritis;

. Avascular Necrosis; and

. Congenital Dislocation.

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/K961939 · printed Nov 5, 2026

Cite this page

510(k) Report. “K961939: S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961939

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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