510(k) Report

510(k) · Cleared

Cleared

Excera Fitrite Total Hip Arthroplasty System

K140547510(k) TraditionalCleared Jan 22, 2015324-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

Excera Orthopedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jan 22, 2015 as substantially equivalent to K061461 (Zimmer, Inc., 2006) and 6 other predicates after a 324-day review. Its family tree reaches back 6 generations to 1985. 1 later device descends from it.

Decided
Jan 22, 2015
Review
324 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
7

Its longest line of descent runs back 6 generations to K850055 (1985). 68 ancestors in all, the oldest K840643 (1984). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2006: 2 other ancestors2004: 4 other ancestors2003: 4 other ancestors2000: 7 other ancestors1994: 9 other ancestors1996: 6 other ancestors2002: 2 other ancestors1998: 4 other ancestors1997: 5 other ancestors2001: 2 other ancestors1999: 2 other ancestors1995: 4 other ancestors1993: 1 other ancestor1990: 1 other ancestor1987: 2 other ancestors1984: 1 other ancestor1988: 2 other ancestors1985: 1 other ancestor1991: 1 other ancestor2016: 1 descendant clearedK850055 · Profile Femoral Hip · Depuy, Inc. · 1985K961378 · Delta Hip Prosthesis · Zimmer, Inc. · 1996 · recalled×2: 2 generations cleared close together, K992667 (1999), K994286 (2000) K032726 · Zimmer M/L Taper Hip Prosthesis, 7711 Series · Zimmer, Inc. · 2003 · recalledK071723 · Zimmer Porolock Mis Stem · Zimmer GmbH · 2008 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 6 other ancestors3 generations back: 10 other ancestors4 generations back: 26 other ancestors5 generations back: 11 other ancestors6 generations back: 2 other ancestors 1 generation forward: 1 descendant K071723 · Zimmer Porolock Mis Stem · Zimmer GmbH · 2008 · recalledK032726 · Zimmer M/L Taper Hip Prosthesis, 7711 Series · Zimmer, Inc. · 2003 · recalledK994286 · ZMR Hip System-Porous Revision · Zimmer, Inc. · 2000 · recalledK992667 · ZMR Hip System-Revision Taper · Zimmer, Inc. · 1999 · recalledK961378 · Delta Hip Prosthesis · Zimmer, Inc. · 1996 · recalledK850055 · Profile Femoral Hip · Depuy, Inc. · 1985−50
  1. Root · 6 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
  2. 5 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
  3. 4 generations backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
  4. 3 generations backK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
  5. 2 generations backK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
  6. 1 generation backK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
  7. This deviceK140547 Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc. · 2015
  8. Descendant · cites it directly · 0 of its ownK153057 FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc. · 2016

Most influential descendants

Showing 1 of 1 · See all
  • K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K850055Profile Femoral HipDepuy, Inc.1985—
−5K961378Delta Hip ProsthesisZimmer, Inc.19964
−4K992667ZMR Hip System-Revision TaperZimmer, Inc.19991
−3K994286ZMR Hip System-Porous RevisionZimmer, Inc.200011
−2K032726Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc.20033
−1K071723Zimmer Porolock Mis StemZimmer GmbH20082
0 (this device)K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.2015—
+1K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198510
198720
198820
199010
199110
199310
199490
199540
199660
199750
199840
199920
200070
200120
200220
200340
200440
200620
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
FIG. 1 — Lineage of K140547, 1985–2016Source: 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? (7)

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
*K061461Mayo Conservative Hip Prosthesis, Model 00.65-8026-010-05
Summary page 4
…tem are substantially equivalent to the following previously cleared devices; 1) The DDH & Standard Stems; Zimmer Mayo® Conservative Hip Prosthesis (K061461) 2) The Cemented stems; Zimmer CPT 12/14 Femoral Stem (K030265) and Zimmer Fitmore (K071723)…
Zimmer, Inc.2006—
*K030265CPT 12/14 Hip Prostheses, Model 00-8114-040/050-00
Summary page 4
…red devices; 1) The DDH & Standard Stems; Zimmer Mayo® Conservative Hip Prosthesis (K061461) 2) The Cemented stems; Zimmer CPT 12/14 Femoral Stem (K030265) and Zimmer Fitmore (K071723) 1…
Zimmer, Inc.20033
*K071723Zimmer Porolock Mis Stem
Summary page 4
…andard Stems; Zimmer Mayo® Conservative Hip Prosthesis (K061461) 2) The Cemented stems; Zimmer CPT 12/14 Femoral Stem (K030265) and Zimmer Fitmore (K071723) 1 of 4…
Zimmer GmbH20082
*K071784Depuy Pinnacle with Gripton Acetabular Cups
Summary page 5
…rthopedics, Inc. January 22, 2015 FitRite™ Total Hip Arthroplasty System 3) The Acetabular Cups; DePuy Pinnacle w/ Gripton (K071784) 4) The Acetabular Liners Screws; DePuy Pinnacle Acetabular System (K001534) 5) The femoral heads; DePuy Ultima™…
DePuy Orthopaedics, Inc.2007—
*K001534Pinnacle Acetabular System
Summary page 5
…l Hip Arthroplasty System 3) The Acetabular Cups; DePuy Pinnacle w/ Gripton (K071784) 4) The Acetabular Liners Screws; DePuy Pinnacle Acetabular System (K001534) 5) The femoral heads; DePuy Ultima™ Unipolar Femoral Head, (K033273) 6) The cement restrictors; Kinamed REALITY,…
DePuy Orthopaedics, Inc.2000—
*K033273Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima…
Summary page 5
…Gripton (K071784) 4) The Acetabular Liners Screws; DePuy Pinnacle Acetabular System (K001534) 5) The femoral heads; DePuy Ultima™ Unipolar Femoral Head, (K033273) 6) The cement restrictors; Kinamed REALITY, (K922247) Description of the Device [21 CFR 807.92(a)(4)] The Excera…
DePuy Orthopaedics, Inc.2004—
*K922247Kinamed Reality Total Hip System
Summary page 5
…uy Pinnacle Acetabular System (K001534) 5) The femoral heads; DePuy Ultima™ Unipolar Femoral Head, (K033273) 6) The cement restrictors; Kinamed REALITY, (K922247) Description of the Device [21 CFR 807.92(a)(4)] The Excera Orthopedics FitMore™ Total Hip Arthroplasty System is intende…
Kinamed, Inc.1994—

Also cleared against K061461: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160

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?

  • The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
  • 18 of the 67 ancestors have a recall of any class.
  • Of its descendants, K153057 (Excera Orthopedics, Inc., 2016) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K061461.

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. 2015, this device’s year, is highlighted.

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?

Total Hip Arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. The Excera FitRite™ Total Hip Arthroplasty System is indicated for total hip replacement in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid…

Read the full statement (137 words)

Total Hip Arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

The Excera FitRite™ Total Hip Arthroplasty System is indicated for total hip replacement in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.

2. Avascular necrosis of the femoral head.

3. Acute traumatic fracture of the femoral head or neck.

4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankylosis.

The FitRite™ DDH Femoral Stems, Standard Femoral Stems, and Acetabular Cups are intended for cementless application; the FitRite™ Cemented Femoral Stems are intended for cemented application.

Indications for use as stated in the FDA summary.

Also cleared against K061461

1 other device cites the same predicate.

  • K112682Metha Hip SystemAesculap Implant Systems, LLC · 2012

More from Excera Orthopedics, Inc.

2 FDA decisions under this applicant name. See the company

  • K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc. · 2016

Recent decisions in LPH

The LPH category page

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  • 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/K140547 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140547: Excera Fitrite Total Hip Arthroplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140547

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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