510(k) Report

510(k) · Cleared

Cleared

ZTT I and II Acetabular Cup of the S-Rom Total Hip System

K951000510(k) TraditionalCleared Apr 14, 199542-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 Apr 14, 1995 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 405 later devices descend from it.

Decided
Apr 14, 1995
Review
42 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

405 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2024: 18 descendants cleared2025: 29 descendants cleared2000: 2 descendants cleared2016: 19 descendants cleared2017: 23 descendants cleared2006: 7 descendants cleared2003: 2 descendants cleared2013: 26 descendants cleared2018: 23 descendants cleared2011: 17 descendants cleared2012: 30 descendants cleared2008: 10 descendants cleared2019: 25 descendants cleared2022: 26 descendants cleared2014: 16 descendants cleared2026: 19 descendants cleared2015: 14 descendants cleared2004: 2 descendants cleared2007: 2 descendants cleared2009: 8 descendants cleared2010: 15 descendants cleared2005: 1 descendant cleared2023: 26 descendants cleared2020: 21 descendants cleared2021: 23 descendants cleared1995200020052010201520202025
  1. This deviceK951000 ZTT I and II Acetabular Cup of the S-Rom Total Hip SystemJoint Medical Products Corp. · 1995
  2. Descendant · cites it directly · 404 of its ownK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
  3. Descendant · 2 generations on · 403 of its ownK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
  4. Descendant · 3 generations on · 267 of its ownK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
  5. Descendant · 3 generations on · 217 of its ownK031110 Apex Modular Acetabular CupApex Surgical, LLC · 2003
  6. Descendant · 3 generations on · 207 of its ownK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003

Showing 5 of 405 descendants. See all descendants

Descendants cleared per year

1998: 12000: 22003: 22004: 22005: 12006: 72007: 22008: 102009: 82010: 152011: 172012: 302013: 262014: 162015: 142016: 192017: 232018: 232019: 252020: 212021: 232022: 262023: 262024: 182025: 292026: 19
1998high 30 (2012) · low 0 (1999)2026

Most influential descendants

Showing 5 of 405 · See all
  • K983014Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998 · cites it directly404descendants
  • K000306Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · 2 generations on403descendants
  • K001534Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · 3 generations on267descendants
  • K031110Apex Modular Acetabular CupApex Surgical, LLC · 2003 · 3 generations on217descendants
  • K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003 · 3 generations on207descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951000ZTT I and II Acetabular Cup of the S-Rom Total Hip SystemJoint Medical Products Corp.1995—
+1K983014Summit Acetabular SystemJohnson & Johnson Professionals, Inc.1998—
+2K000306Pinnacle Acetabular SystemDePuy Orthopaedics, Inc.20001
+3K001534Pinnacle Acetabular SystemDePuy Orthopaedics, Inc.2000—
+3K031110Apex Modular Acetabular CupApex Surgical, LLC2003—
+3K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200020
200320
200420
200510
200670
200720
2008100
200980
2010150
2011170
2012300
2013260
2014160
2015140
2016190
2017230
2018230
2019250
2020210
2021230
2022260
2023260
2024180
2025290
2026190
FIG. 1 — Lineage of K951000, 1995–2026Source: 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
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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? (405)

See all 405

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

NumberDeviceApplicantDecidedDescendants
K983014Summit Acetabular SystemJohnson & Johnson Professionals, Inc.1998404
K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245

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, K983014 (Johnson & Johnson Professionals, Inc., 1998) has gone furthest, with 404 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
  • 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 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/K951000 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951000: ZTT I and II Acetabular Cup of the S-Rom Total Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951000

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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