510(k) Report

510(k) · Cleared

Cleared

S-Rom (TM) Total Lhip System W/Ceramic Head

K913231510(k) TraditionalCleared Dec 20, 1991151-day reviewClass II21 CFR 888.3350

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. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Dec 20, 1991 after a 151-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 329 later devices descend from it.

Decided
Dec 20, 1991
Review
151 days
Class
Class II
Product code
JDI
Recalls
None
Predicates
0

329 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 1998: 2 descendants cleared2000: 4 descendants cleared2004: 7 descendants cleared1996: 1 descendant cleared2021: 16 descendants cleared2010: 9 descendants cleared2017: 14 descendants cleared2024: 25 descendants cleared2005: 4 descendants cleared2007: 1 descendant cleared2006: 2 descendants cleared2013: 16 descendants cleared2008: 6 descendants cleared2019: 18 descendants cleared2020: 18 descendants cleared2011: 12 descendants cleared2015: 9 descendants cleared2016: 10 descendants cleared2022: 25 descendants cleared2025: 31 descendants cleared2026: 29 descendants cleared2001: 1 descendant cleared2018: 16 descendants cleared2012: 14 descendants cleared2009: 2 descendants cleared2014: 7 descendants cleared2023: 30 descendants cleared1990200020102020
  1. This deviceK913231 S-Rom (TM) Total Lhip System W/Ceramic HeadJoint Medical Products Corp. · 1991
  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 · 2 generations on · 189 of its ownK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
  4. Descendant · 3 generations on · 188 of its ownK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
  5. Descendant · 4 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 329 descendants. See all descendants

Descendants cleared per year

1996: 11998: 22000: 42001: 12004: 72005: 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 329 · 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 · 2 generations on189descendants
  • K001991Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000 · 3 generations on188descendants
  • K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · 4 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)K913231S-Rom (TM) Total Lhip System W/Ceramic HeadJoint Medical Products Corp.1991—
+1K961939S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc.1996—
+2K974331Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc.1998—
+3K001991Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc.2000—
+4K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc.20051
+1K000788Apex Modular Hip StemApex Surgical, LLC2000—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199820
200040
200110
200470
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 K913231, 1991–2026Source: 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 JDI? 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 JDI device

  1. #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
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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? (329)

See all 329

5 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
K000788Apex Modular Hip StemApex Surgical, LLC2000168
K980020Activelock Modular Femoral Hip SystemMetagen, LLC19982
K992815The Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd.20001
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 JDI devices

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

FDA decisions per year · JDI

1in 2025

2007: 32008: 52009: 32011: 22012: 42013: 32014: 32015: 32016: 42017: 12018: 12019: 22020: 72021: 32022: 32023: 22024: 32025: 12026 (partial year): 2
2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007: 81 days median2008: 96 days median2009: 65 days median2012: 167 days median2013: 176 days median2014: 98 days median2015: 190 days median2016: 166 days median2020: 247 days median2021: 162 days median2022: 69 days median2024: 59 days median
2007high 247 (2020) · low 59 (2024)2026

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

Recalls per year · JDI

1in 2025

2007: 262008: 62009: 32010: 32011: 52012: 42013: 112014: 32015: 12016: 52017: 52018: 12019: 12020: 772025: 1
2007high 77 (2020) · low 0 (2021)2026

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

Adverse event reports per year · JDI

1,644in 2025

2007: 6962008: 8102009: 9642010: 2,0402011: 3,1602012: 5,1222013: 5,2062014: 4,9682015: 4,9062016: 3,9952017: 6,1352018: 6,7282019: 7,4072020: 4,0152021: 3,1702022: 1,9782023: 1,6352024: 1,8212025: 1,644
2007high 7,407 (2019) · low 696 (2007)2025

MAUDE reports naming product code JDI, 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
200738126696
20085966810
20093653964
20100—32,040
20112—53,160
2012416745,122
20133176115,206
201439834,968
2015319014,906
2016416653,995
20171—56,135
20181—16,728
20192—17,407
20207247774,015
2021316203,170
202236901,978
20232—01,635
202435901,821
20251—11,644
20262—0—

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
  • K954935S-Rom Femoral Hip Stem - Size 14 X 8Joint 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

Recent decisions in JDI

The JDI category page

  • K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026
  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet · 2025
  • K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip…Smith & Nephew, Inc. · 2024
  • K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024

https://510kreport.com/device/K913231 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913231: S-Rom (TM) Total Lhip System W/Ceramic Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913231

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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