510(k) Report

510(k) · Cleared

Cleared

Pantheon Proximal Femur Reconstruction (PFR) System

K241059510(k) TraditionalCleared Jan 13, 2025270-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

Adler Ortho S.P.A · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jan 13, 2025 as substantially equivalent to K023087 (Howmedica Osteonics Corp., 2002) and 6 other predicates after a 270-day review. Its family tree reaches back 9 generations to 1994.

Decided
Jan 13, 2025
Review
270 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
7

Its longest line of descent runs back 9 generations to K931641 (1994). 107 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2008: 1 other ancestor2007: 4 other ancestors2004: 4 other ancestors2002: 5 other ancestors1998: 7 other ancestors2010: 1 other ancestor2009: 1 other ancestor2006: 3 other ancestors2005: 5 other ancestors2000: 9 other ancestors1997: 4 other ancestors1996: 8 other ancestors1995: 8 other ancestors1994: 13 other ancestors1988: 1 other ancestor1985: 3 other ancestors2003: 3 other ancestors2001: 2 other ancestors1999: 5 other ancestors1993: 4 other ancestors1992: 2 other ancestors1991: 1 other ancestor1981: 1 other ancestor1986: 2 other ancestorsK931641 · Porocoat Porous Coating · Depuy, Inc. · 1994K003800 · Aml Hip Prosthesis · DePuy Orthopaedics, Inc. · 2001K012364 · Aml Hip Prosthesis · DePuy Orthopaedics, Inc. · 2001K030236 · Acumatch P-Series Porous Press-Fit Femoral Component · Exactech, Inc. · 2003K041906 · Exactech 12/14 Total Hip System · Exactech, Inc. · 2004 · recalledK051556 · Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene · Exactech, Inc. · 2005 · recalledK070479 · Exactech Novation Crown Cup and Liners · Exactech, Inc. · 2007 · recalledK102975 · Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole · Exactech, Inc. · 2010K112898 · Delta TT Cups, Delta TT Liners, Bone Screws · Lima Corporate S.P.A. · 201219801990200020102020
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 25 other ancestors3 generations back: 17 other ancestors4 generations back: 17 other ancestors5 generations back: 17 other ancestors6 generations back: 12 other ancestors7 generations back: 3 other ancestors8 generations back: 1 other ancestor K112898 · Delta TT Cups, Delta TT Liners, Bone Screws · Lima Corporate S.P.A. · 2012K102975 · Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole · Exactech, Inc. · 2010K070479 · Exactech Novation Crown Cup and Liners · Exactech, Inc. · 2007 · recalledK051556 · Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene · Exactech, Inc. · 2005 · recalledK041906 · Exactech 12/14 Total Hip System · Exactech, Inc. · 2004 · recalledK030236 · Acumatch P-Series Porous Press-Fit Femoral Component · Exactech, Inc. · 2003K012364 · Aml Hip Prosthesis · DePuy Orthopaedics, Inc. · 2001K003800 · Aml Hip Prosthesis · DePuy Orthopaedics, Inc. · 2001K931641 · Porocoat Porous Coating · Depuy, Inc. · 1994−50
  1. Root · 9 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
  2. 5 generations between
  3. 3 generations backK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · Recalled
  4. 2 generations backK102975 Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc. · 2010
  5. 1 generation backK112898 Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A. · 2012
  6. This deviceK241059 Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A · 2025
Show all 9 generations
  1. Root · 9 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
  2. 8 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
  3. 7 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
  4. 6 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
  5. 5 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
  6. 4 generations backK051556 Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · Recalled
  7. 3 generations backK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · Recalled
  8. 2 generations backK102975 Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc. · 2010
  9. 1 generation backK112898 Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A. · 2012
  10. This deviceK241059 Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K931641Porocoat Porous CoatingDepuy, Inc.1994—
−8K003800Aml Hip ProsthesisDePuy Orthopaedics, Inc.2001—
−7K012364Aml Hip ProsthesisDePuy Orthopaedics, Inc.2001—
−6K030236Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc.2003—
−5K041906Exactech 12/14 Total Hip SystemExactech, Inc.20041
−4K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc.200512
−3K070479Exactech Novation Crown Cup and LinersExactech, Inc.200716
−2K102975Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc.2010—
−1K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.2012—
0 (this device)K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198530
198620
198810
199110
199220
199340
1994130
199580
199680
199740
199870
199950
200090
200120
200250
200330
200440
200550
200630
200740
200810
200910
201010
201110
FIG. 1 — Lineage of K241059, 1994–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K023087Global Modular Replacement System (GMRS)
Summary page 6
…Adler Ortho S.p.A. Primary Predicate: Global Modular Replacement System (GMRS®) Proximal Femoral (K023087) Additional Predicates: Global Modular Replacement System (GMRS®) Proximal Femoral (K04…
Howmedica Osteonics Corp.20022
*K040749Modular Replacement System Cemented Stems
Summary page 6
…Femoral (K023087) Additional Predicates: Global Modular Replacement System (GMRS®) Proximal Femoral (K040749) M-SPEC Metal Femoral Heads (K980513) Biolox Delta Ceramic Femora…
Howmedica Osteonics Corp.20041
*K980513Articul/Eze Femoral Heads
Summary page 6
…Global Modular Replacement System (GMRS®) Proximal Femoral (K040749) M-SPEC Metal Femoral Heads (K980513) Biolox Delta Ceramic Femoral Heads (K071535) Delta TT Acetabular…
DePuy Orthopaedics, Inc.1998—
*K071535Biolox Delta Ceramic Femoral Head
Summary page 6
…Femoral (K040749) M-SPEC Metal Femoral Heads (K980513) Biolox Delta Ceramic Femoral Heads (K071535) Delta TT Acetabular System (K112898) Pinnacle Altrx Polyethylene…
Zimmer, Inc.20073
*K112898Delta TT Cups, Delta TT Liners, Bone Screws
Summary page 6
…EC Metal Femoral Heads (K980513) Biolox Delta Ceramic Femoral Heads (K071535) Delta TT Acetabular System (K112898) Pinnacle Altrx Polyethylene Acetabular Liner (K072963) Zimmer® S…
Lima Corporate S.P.A.2012—
*K072963Depuy Pinnacle Altrx Acetabular Liners
Summary page 6
…emoral Heads (K071535) Delta TT Acetabular System (K112898) Pinnacle Altrx Polyethylene Acetabular Liner (K072963) Zimmer® Segmental System Trabecular Metal Proximal Tibial Compon…
DePuy Orthopaedics, Inc.2008—
*K110940Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal…
Summary page 6
…t, Trabecular Metal Proximal Femoral Component, and additional Segment with Male/Female Taper components (K110940) Indications for Use: The Pantheon Proximal Femur Reconstruction (PFR) System is a modular system intended to be used for the re…
Zimmer, Inc.2011—

Also cleared against K023087: 11 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 31 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
  • 30 of the 107 ancestors have a recall of any class.
  • 11 other devices also cite its predicate K023087.

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. 2025, 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?

The Pantheon Proximal Femur Reconstruction (PFR) System is a modular system intended to be used for the reconstruction of the proximal femur in the case of severe proximal femoral bone loss in hip revision surgery (due to infection, fracture, failed THA) or in the case of a bone tumor.

The FIXA Ti-Por cup is intended for cementless use.

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 K023087

11 other devices cite the same predicate.

  • K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
  • K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024
  • K222056Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 20231 recall
  • K181778MUTARS Proximal Femur Replacement SystemImplantcast GmbH · 2019
  • K151008Link® Megasystem-C®Waldemar Link GmbH & Co. KG · 201516 recalls
  • K122015Distal Femoral Growing Prosthesis, Tibial Rotating Components, Bearing, Axis, Circlip, WedgeHowmedica Osteonics Corp. · 2013

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/K241059 · printed Nov 6, 2026

Cite this page

510(k) Report. “K241059: Pantheon Proximal Femur Reconstruction (PFR) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241059

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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