510(k) · Cleared
ClearedKlassic HD (TM) Extended Offset Femoral Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Total Joint Orthopedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Feb 12, 2014 as substantially equivalent to K100445 (Total Joint Orthopedics, Inc., 2010) and 3 other predicates after a 268-day review. Its family tree reaches back 9 generations to 1981. 2 later devices descend from it.
- Decided
- Feb 12, 2014
- Review
- 268 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K810258 (1981). 96 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 5 generations between
- 3 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 2 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 1 generation backK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
- This deviceK131454 Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK151440 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK171962 Klassic HD® Hip SystemTotal Joint Othopedics, Inc. · 2017
Show all 9 generations
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 7 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 6 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 5 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 4 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 3 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 2 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 1 generation backK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
- This deviceK131454 Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −8 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −7 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −6 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −5 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −4 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −3 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −2 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −1 | K100445 | Klassic HD Hip System | Total Joint Orthopedics, Inc. | 2010 | — |
| 0 (this device) | K131454 | Klassic HD (TM) Extended Offset Femoral Head | Total Joint Orthopedics, Inc. | 2014 | — |
| +1 | K151440 | Klassic HD Hip System | Total Joint Orthopedics, Inc. | 2015 | — |
| +2 | K171962 | Klassic HD® Hip System | Total Joint Othopedics, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 12 | 0 |
| 1995 | 10 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 10 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
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 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K100445 | Klassic HD Hip SystemSummary page 2…quire a total hip replacement. PRODUCT DESCRIPTION The Klassic Tm HD Extended Offset Femoral Head is a modular component to be used within the Klassic HDOT Hip System (K100445). The Kiassic HO T Extended Offset Femoral Head is to be used within the System as an optional prosthesis to the Klassic HDTM Fem… | 2010 |
| * | K103479 | Novel Tapered Hip StemSummary page 2…510(k) SUMMARY PREDICATE DEVICE(S) * Total Joint Orthopedics Kiassic HD TmHip System (KI100445) * Accolade II Femoral Hip Stem, Howmedica Osteonics, Corp. (K103479) * Alloclassic Zweymuller SL Offset Femoral Stem, Centerpulse Orthopedics (K033664) * Modular Femoral Head with Offse… | 2011 |
| * | K033664 | Modification to Alloclassic Zweymuller SL Offset Femoral StemSummary page 2…tem (KI100445) * Accolade II Femoral Hip Stem, Howmedica Osteonics, Corp. (K103479) * Alloclassic Zweymuller SL Offset Femoral Stem, Centerpulse Orthopedics (K033664) * Modular Femoral Head with Offset Trunion, Kirschner Medical Corp (K9 14675) INDICATIONS FOR USE… | 2003 |
| * | K914675 | Modular Femoral Head with Offset TrunionSummary page 2…03479) * Alloclassic Zweymuller SL Offset Femoral Stem, Centerpulse Orthopedics (K033664) * Modular Femoral Head with Offset Trunion, Kirschner Medical Corp (K9 14675) INDICATIONS FOR USE Tm The Kiassic HDTm Extended… | 1992 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151440 | Klassic HD Hip System | 2015 | 1 |
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 33 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 25 of the 96 ancestors have a recall of any class.
- Of its descendants, K151440 (Total Joint Orthopedics, Inc., 2015) has gone furthest, with 1 descendant of its own.
- 11 other devices also cite its predicate K100445.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
The Klassic HD Extended Offset Femoral Head for use within the Klassic HD Hip System is intended for prosthetic replacement without bone cement in treatment of the following:
• Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
• Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
• Those patients with failed previous surgery where pain, deformity or dysfunction persists.
• Revision of a previously failed hip arthroplasty.
• Patients who require a total hip replacement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131454: Klassic HD (TM) Extended Offset Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131454
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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