510(k) Report

510(k) · Cleared

Cleared

S-Rom Femoral Hip Stem - Size 14 X 8

K954935510(k) TraditionalCleared Jan 22, 199687-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

Joint Medical Products Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jan 22, 1996 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 326 later devices descend from it.

Decided
Jan 22, 1996
Review
87 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

326 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2000: 3 descendants cleared2017: 14 descendants cleared2004: 6 descendants cleared2005: 4 descendants cleared1996: 1 descendant cleared2021: 16 descendants cleared2010: 9 descendants cleared2024: 25 descendants cleared2013: 16 descendants cleared2008: 6 descendants cleared2022: 25 descendants cleared2007: 1 descendant cleared2006: 2 descendants cleared2020: 18 descendants cleared2001: 1 descendant cleared2018: 16 descendants cleared2019: 18 descendants cleared2012: 14 descendants cleared2011: 12 descendants cleared2015: 9 descendants cleared2016: 10 descendants cleared2023: 30 descendants cleared2025: 31 descendants cleared2026: 29 descendants cleared2009: 2 descendants cleared2014: 7 descendants cleared1995200020052010201520202025
  1. This deviceK954935 S-Rom Femoral Hip Stem - Size 14 X 8Joint Medical Products Corp. · 1996
  2. 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
  3. Descendant · cites it directly · 189 of its ownK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
  4. Descendant · 2 generations on · 188 of its ownK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
  5. Descendant · 3 generations on · 168 of its ownK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
  6. Descendant · cites it directly · 168 of its ownK000788 Apex Modular Hip StemApex Surgical, LLC · 2000

Showing 5 of 326 descendants. See all descendants

Descendants cleared per year

1996: 11998: 12000: 32001: 12004: 62005: 42006: 22007: 12008: 62009: 22010: 92011: 122012: 142013: 162014: 72015: 92016: 102017: 142018: 162019: 182020: 182021: 162022: 252023: 302024: 252025: 312026: 29
1996high 31 (2025) · low 0 (1997)2026

Most influential descendants

Showing 5 of 326 · 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
  • K000788Apex Modular Hip StemApex Surgical, LLC · 2000 · cites it directly168descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954935S-Rom Femoral Hip Stem - Size 14 X 8Joint Medical Products Corp.1996—
+1K961939S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc.1996—
+1K974331Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc.1998—
+2K001991Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc.2000—
+3K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc.20051
+1K000788Apex Modular Hip StemApex Surgical, LLC2000—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
200030
200110
200460
200540
200620
200710
200860
200920
201090
2011120
2012140
2013160
201470
201590
2016100
2017140
2018160
2019180
2020180
2021160
2022250
2023300
2024250
2025310
2026290
FIG. 1 — Lineage of K954935, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (326)

See all 326

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

NumberDeviceApplicantDecidedDescendants
K961939S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc.1996210
K974331Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc.1998189
K000788Apex Modular Hip StemApex Surgical, LLC2000168
K042127Smith & Nephew Modular HipSmith & Nephew, Inc.200417
K052426Smith & Nephew Modular HipSmith & Nephew, Inc.20056
K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.20174
K032730Fixion Hip SystemDisc-O-Tech Medical Technologies, Ltd.20040

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, K961939 (Johnson & Johnson Professionals, Inc., 1996) has gone furthest, with 210 descendants of its own.

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

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

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

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
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

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

More from Joint Medical Products Corp.

33 FDA decisions under this applicant name. See the company

  • K955511Arthopor I & II Acetabular Cup/Arthopor II Oblong Acetabular CupJoint Medical Products Corp. · 1996
  • K944321S-Rom Noiles Posterior Stabilized Total Knee System IIJoint Medical Products Corp. · 1995
  • K951726S-Rom ZTP Uhmwpe Acetabular CupJoint Medical Products Corp. · 1995
  • K951084S-Rom Opc (One-Piece Cemented) II Femoral Hip ProsthesisJoint Medical Products Corp. · 1995
  • K951000ZTT I and II Acetabular Cup of the S-Rom Total Hip SystemJoint Medical Products Corp. · 1995

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K954935 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954935: S-Rom Femoral Hip Stem - Size 14 X 8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954935

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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