510(k) Report

510(k) · Cleared

Cleared

Perfecta RS Lateralized Hip Stem, Bridge Hip System

K991123510(k) AbbreviatedCleared Jun 1, 199960-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

Wrightmedicaltechnologyinc · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jun 1, 1999 after a 60-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.

Decided
Jun 1, 1999
Review
60 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 1 descendant cleared2006: 1 descendant cleared2018: 1 descendant cleared2009: 1 descendant cleared2014: 1 descendant cleared2015: 1 descendant cleared1995200020052010201520202025
  1. This deviceK991123 Perfecta RS Lateralized Hip Stem, Bridge Hip SystemWrightmedicaltechnologyinc · 1999
  2. Descendant · cites it directly · 4 of its ownK061344 Excia Total Hip System Lateral OffsetAesculap, Inc. · 2006
  3. Descendant · 2 generations on · 3 of its ownK092143 Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc. · 2009
  4. Descendant · 3 generations on · 2 of its ownK140915 Excia Total Hip SystemAesculap Implant Systems, LLC · 2014
  5. Descendant · 4 generations on · 1 of its ownK150062 Excia Total Hip SystemAesculap Implant Systems, LLC · 2015
  6. Descendant · 2 generations on · 0 of its ownK172235 CoreHip® SystemAesculap Implants Systems, LLC · 2018

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2004: 12006: 12009: 12014: 12015: 12018: 1
2004high 1 (2004) · low 0 (2005)2026

Most influential descendants

Showing 5 of 6 · See all
  • K061344Excia Total Hip System Lateral OffsetAesculap, Inc. · 2006 · cites it directly4descendants
  • K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc. · 2009 · 2 generations on3descendants
  • K140915Excia Total Hip SystemAesculap Implant Systems, LLC · 2014 · 3 generations on2descendants
  • K150062Excia Total Hip SystemAesculap Implant Systems, LLC · 2015 · 4 generations on1descendant
  • K172235CoreHip® SystemAesculap Implants Systems, LLC · 2018 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K991123Perfecta RS Lateralized Hip Stem, Bridge Hip SystemWrightmedicaltechnologyinc1999—
+1K061344Excia Total Hip System Lateral OffsetAesculap, Inc.2006—
+2K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.2009—
+3K140915Excia Total Hip SystemAesculap Implant Systems, LLC2014—
+4K150062Excia Total Hip SystemAesculap Implant Systems, LLC2015—
+2K172235CoreHip® SystemAesculap Implants Systems, LLC2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200610
200910
201410
201510
201810
FIG. 1 — Lineage of K991123, 1999–2018Source: 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 24.3 · 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? (2)

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
*—Dual Offset PERFECTA® IMC Hip Stem
Named without a submission number
—
*—BRIDGE® Hip System
Named without a submission number
—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064
K031402Perfecta Femoral StemWrightmedicaltechnologyinc20040

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, K061344 (Aesculap, Inc., 2006) has gone furthest, with 4 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—

What is it indicated for?

This device is indicated in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

Inflammatory degenerative joint disease such as rheumatoid arthritis;

Correction of function deformity;

Revision procedures where other treatments or devices have failed; and

Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

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

Cite this page

510(k) Report. “K991123: Perfecta RS Lateralized Hip Stem, Bridge 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/K991123

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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