510(k) Report

510(k) · Cleared

Cleared

P.F.C. Total Hip System Porous Coated Modular

K930712510(k) TraditionalCleared Oct 4, 1993235-day reviewClass II21 CFR 888.3353

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Johnson & Johnson Orthopaedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Oct 4, 1993 after a 235-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
Oct 4, 1993
Review
235 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
0

405 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2024: 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 cleared1990200020102020
  1. This deviceK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
  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)K930712P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc.1993—
+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 K930712, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LZO? 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 LZO device

  1. #1 K192827 Quadra-Pscore 19.3 · 10 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

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K983014Summit Acetabular SystemJohnson & Johnson Professionals, Inc.1998404

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 LZO devices

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

FDA decisions per year · LZO

14in 2025

2007: 92008: 112009: 72010: 152011: 132012: 142013: 262014: 132015: 122016: 102017: 162018: 182019: 282020: 182021: 122022: 112023: 102024: 112025: 142026 (partial year): 9
2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007: 87 days median2008: 63 days median2009: 83 days median2010: 78 days median2011: 87 days median2012: 98 days median2013: 100 days median2014: 85 days median2015: 115 days median2016: 177 days median2017: 257 days median2018: 163 days median2019: 109 days median2020: 112 days median2021: 170 days median2022: 279 days median2023: 122 days median2024: 111 days median2025: 119 days median2026 (partial year): 102 days median
2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007: 22008: 132009: 422011: 102012: 142014: 12015: 12016: 92017: 52018: 22019: 42020: 32022: 42023: 22024: 12025: 1
2007high 42 (2009) · low 0 (2010)2026

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

Adverse event reports per year · LZO

3,244in 2025

2007: 1382008: 1252009: 1892010: 3942011: 5442012: 9632013: 1,3702014: 1,4772015: 1,3482016: 1,7282017: 2,1652018: 3,1332019: 3,0662020: 1,9632021: 2,1992022: 1,9852023: 2,0662024: 2,5862025: 3,244
2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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
20079872138
2008116313125
200978342189
201015780394
2011138710544
2012149814963
20132610001,370
2014138511,477
20151211511,348
20161017791,728
20171625752,165
20181816323,133
20192810943,066
20201811231,963
20211217002,199
20221127941,985
20231012222,066
20241111112,586
20251411913,244
202691020—

More from Johnson & Johnson Orthopaedics, Inc.

22 FDA decisions under this applicant name. See the company

  • K931466PFC Modular Total Knee System, Porous Coated SacriJohnson & Johnson Orthopaedics, Inc. · 1994
  • K935452P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
  • K940190Ultima Unipolar Modular HeadJohnson & Johnson Orthopaedics, Inc. · 1994
  • K933275P.F.C. Ceramic Hip HeadJohnson & Johnson Orthopaedics, Inc. · 1994
  • K932595Orthosorb (TM) Absorbable Cement RestrictorJohnson & Johnson Orthopaedics, Inc. · 1994

Recent decisions in LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K260831Z1 Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K930712 · printed Nov 6, 2026

Cite this page

510(k) Report. “K930712: P.F.C. Total Hip System Porous Coated Modular.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930712

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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