510(k) Report

510(k) · Cleared

Cleared

Summit Acetabular System

K983014510(k) TraditionalCleared Oct 27, 199860-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 Oct 27, 1998 as substantially equivalent to K951000 (Joint Medical Products Corp., 1995) and 4 other predicates after a 60-day review. Its family tree reaches back 1 generation to 1993. 404 later devices descend from it.

Decided
Oct 27, 1998
Review
60 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K930712 (1993). 5 ancestors in all. 404 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 2 other ancestors1994: 1 other ancestor2024: 18 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 cleared2025: 29 descendants cleared2015: 14 descendants cleared2004: 2 descendants cleared2007: 2 descendants cleared2009: 8 descendants cleared2010: 15 descendants cleared2005: 1 descendant cleared2023: 26 descendants cleared2026: 19 descendants cleared2020: 21 descendants cleared2021: 23 descendants clearedK930712 · P.F.C. Total Hip System Porous Coated Modular · Johnson & Johnson Orthopaedics, Inc. · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 21 descendants3 generations forward: 48 descendants4 generations forward: 88 descendants5 generations forward: 97 descendants6 generations forward: 52 descendants7 generations forward: 31 descendants8 generations forward: 24 descendants9 generations forward: 28 descendants10 generations forward: 7 descendants11 generations forward: 3 descendants12 generations forward: 3 descendants K930712 · P.F.C. Total Hip System Porous Coated Modular · Johnson & Johnson Orthopaedics, Inc. · 19930+5+10
  1. Root · 1 generation backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
  2. This deviceK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
  3. Descendant · cites it directly · 403 of its ownK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
  4. Descendant · 2 generations on · 267 of its ownK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
  5. Descendant · 2 generations on · 217 of its ownK031110 Apex Modular Acetabular CupApex Surgical, LLC · 2003
  6. Descendant · 2 generations on · 207 of its ownK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
  7. Descendant · 3 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled

Showing 5 of 404 descendants. See all descendants

Descendants cleared per year

2000: 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
2000high 30 (2012) · low 0 (2001)2026

Most influential descendants

Showing 5 of 404 · See all
  • K000306Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · cites it directly403descendants
  • K001534Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · 2 generations on267descendants
  • K031110Apex Modular Acetabular CupApex Surgical, LLC · 2003 · 2 generations on217descendants
  • K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003 · 2 generations on207descendants
  • K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 3 generations on198descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K930712P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc.1993—
0 (this device)K983014Summit Acetabular SystemJohnson & Johnson Professionals, Inc.1998—
+1K000306Pinnacle Acetabular SystemDePuy Orthopaedics, Inc.20001
+2K001534Pinnacle Acetabular SystemDePuy Orthopaedics, Inc.2000—
+2K031110Apex Modular Acetabular CupApex Surgical, LLC2003—
+2K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc.2003—
+3K042344Excia Total Hip SystemAesculap, Inc.200510

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199520
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
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 K983014, 1993–2026Source: 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), 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. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 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? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K951000ZTT I and II Acetabular Cup of the S-Rom Total Hip System
Summary page 2
…MMIT™ Acetabular System is substantially equivalent in terms of intended use, materials, design, sterilization method, and packaging to the ZTT™ | and Il Acetabular Cup (K951000), Arthopor™ | and Il (K955511), PFC ™ Acetabular Cup (K931189 and K930712) and the DePuy DURALOC ® 300 Series (K951301). The det…
Joint Medical Products Corp.1995—
*K955511Arthopor I & II Acetabular Cup/Arthopor II Oblong Acetabular Cup
Summary page 2
…stantially equivalent in terms of intended use, materials, design, sterilization method, and packaging to the ZTT™ | and Il Acetabular Cup (K951000), Arthopor™ | and Il (K955511), PFC ™ Acetabular Cup (K931189 and K930712) and the DePuy DURALOC ® 300 Series (K951301). The determination of substantial equi…
Joint Medical Products Corp.1996—
*K931189P.F.C. Total Hip System Porous Coated Modular Acet
Summary page 2
…f intended use, materials, design, sterilization method, and packaging to the ZTT™ | and Il Acetabular Cup (K951000), Arthopor™ | and Il (K955511), PFC ™ Acetabular Cup (K931189 and K930712) and the DePuy DURALOC ® 300 Series (K951301). The determination of substantial equivalence for this device was base…
Johnson & Johnson Orthopaedics, Inc.1994—
*K930712P.F.C. Total Hip System Porous Coated Modular
Summary page 2
…se, materials, design, sterilization method, and packaging to the ZTT™ | and Il Acetabular Cup (K951000), Arthopor™ | and Il (K955511), PFC ™ Acetabular Cup (K931189 and K930712) and the DePuy DURALOC ® 300 Series (K951301). The determination of substantial equivalence for this device was based on a deta…
Johnson & Johnson Orthopaedics, Inc.1993—
*K951301Depuy Duraloc Cementless Acetabular Cup System
Summary page 2
…and packaging to the ZTT™ | and Il Acetabular Cup (K951000), Arthopor™ | and Il (K955511), PFC ™ Acetabular Cup (K931189 and K930712) and the DePuy DURALOC ® 300 Series (K951301). The determination of substantial equivalence for this device was based on a detailed device description, performance testing…
Depuy, Inc.1995—

Also cleared against K951000: 1 other device →

What descends from it? (404)

See all 404

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

NumberDeviceApplicantDecidedDescendants
K000306Pinnacle Acetabular SystemDePuy Orthopaedics, Inc.2000403
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?

  • None of the 5 ancestors has a recall.
  • Of its descendants, K000306 (DePuy Orthopaedics, Inc., 2000) has gone furthest, with 403 descendants of its own.
  • 1 other device also cites its predicate K951000.

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—

What is it indicated for?

The SUMMIT™ Acetabular System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia…

Read the full statement (94 words)

The SUMMIT™ Acetabular System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

All SUMMIT™ porous-coated acetabular shells are indicated for cementless application.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K951000

1 other device cites the same predicate.

  • K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional…Depuy Ireland UC · 2024

More from Johnson & Johnson Professionals, Inc.

206 FDA decisions under this applicant name. See the company

  • K992173Siphonguard CSF Control DeviceJohnson & Johnson Professionals, Inc. · 2000
  • K991413Codman Ethisorb Dura PatchJohnson & Johnson Professionals, Inc. · 2000
  • K991222Codman Microsensor Ventricular Catheter KitJohnson & Johnson Professionals, Inc. · 1999
  • K982379Sundt Slim-Line Aneurysm Clip ApplierJohnson & Johnson Professionals, Inc. · 1998
  • K982812G2 Total Hip System Femoral Stem (11/13 Taper)Johnson & Johnson Professionals, Inc. · 1998

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/K983014 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983014: Summit Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983014

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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