510(k) · Cleared
ClearedKlassic HD Hip System
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 Dec 3, 2010 as substantially equivalent to K073068 (Accelerated Innovation, LLC, 2008) and 9 other predicates after a 289-day review. Its family tree reaches back 8 generations to 1981. 25 later devices descend from it.
- Decided
- Dec 3, 2010
- Review
- 289 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 8 generations to K810258 (1981). 74 ancestors in all. 25 later devices descend from it, 12 citing it directly.
- Root · 8 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 6 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 5 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 4 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 3 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 2 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 1 generation backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- This deviceK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
- Descendant · cites it directly · 16 of its ownK143407 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2014
- Descendant · cites it directly · 14 of its ownK141972 Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
- Descendant · 2 generations on · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
- Descendant · 2 generations on · 6 of its ownK173104 Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD®…Total Joint Orthopedics, Inc. · 2017
- Descendant · cites it directly · 6 of its ownK161073 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2016
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2014 · cites it directly16descendants
- K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014 · cites it directly14descendants
- K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · 2 generations on9descendants
- K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc. · 2017 · 2 generations on6descendants
- K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2016 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −7 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −6 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −5 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −4 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −3 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −2 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −1 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| 0 (this device) | K100445 | Klassic HD Hip System | Total Joint Orthopedics, Inc. | 2010 | — |
| +1 | K143407 | Klassic HD Hip System | Total Joint Othopedics, Inc. | 2014 | — |
| +1 | K141972 | Klassic HD Acetabular Insert with E-Link Poly | Total Joint Orthopedics, Inc. | 2014 | — |
| +2 | K163577 | Ecofit® Hip System | Implantcast GmbH | 2017 | 1 |
| +2 | K173104 | Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low… | Total Joint Orthopedics, Inc. | 2017 | — |
| +1 | K161073 | Klassic HD Hip System | Total Joint Othopedics, Inc. | 2016 | — |
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 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 9 | 0 |
| 1995 | 6 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 8 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (10)
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 |
|---|---|---|---|
| * | K073068 | Accin Hip SystemSummary page 2…510(k) PREMARKET NOTIFICATION 510(k) SUMMARY (CONT.) PREDICATE DEVICES * Accelerated Innovation, L.L.C., Accin m Hip System (K073068) * Centerpulse Orthopedics Ltd., Alloclassic TM Zweymueller TM SL/SLL Femoral Stem (K030373) * Encore Orthopedics, Inc… | 2008 |
| * | K030373 | Alloclassic Zweymueller SL/SLL Femoral StemSummary page 2…ATE DEVICES * Accelerated Innovation, L.L.C., Accin m Hip System (K073068) * Centerpulse Orthopedics Ltd., Alloclassic TM Zweymueller TM SL/SLL Femoral Stem (K030373) * Encore Orthopedics, Inc., Foundation® Porous Hip Stem (K99 1226) * Howmedica Osteonics Corp., V-40 '/C-Taper Adapter Sle… | 2003 |
| * | K991226 | Foundation Porous Hip StemSummary page 2…(K073068) * Centerpulse Orthopedics Ltd., Alloclassic TM Zweymueller TM SL/SLL Femoral Stem (K030373) * Encore Orthopedics, Inc., Foundation® Porous Hip Stem (K99 1226) * Howmedica Osteonics Corp., V-40 '/C-Taper Adapter Sleeve (K05 1737) * Encore Medical, L.P., Biolox® delta Ceramic Femor… | 1999 |
| * | K051737 | Modification to V-40/C-Taper Adapter SleeveSummary page 2…M SL/SLL Femoral Stem (K030373) * Encore Orthopedics, Inc., Foundation® Porous Hip Stem (K99 1226) * Howmedica Osteonics Corp., V-40 '/C-Taper Adapter Sleeve (K05 1737) * Encore Medical, L.P., Biolox® delta Ceramic Femoral Head and Biolox®0 delta Ceramic Femoral Offset Sleeve (K082844)… | 2005 |
| * | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveSummary page 2…cs Corp., V-40 '/C-Taper Adapter Sleeve (K05 1737) * Encore Medical, L.P., Biolox® delta Ceramic Femoral Head and Biolox®0 delta Ceramic Femoral Offset Sleeve (K082844) * Encore Medical, L.P., Foundation® Porous Coated (FMP Tm) Acetabular Shells (K(072888) * Smith & Nephew, Inc., R… | 2008 |
| * | K072888 | Revelation and Linear Hip Stems and FMP Acetabular Shells (Spiked, Hemispherical and…Summary page 2…mic Femoral Head and Biolox®0 delta Ceramic Femoral Offset Sleeve (K082844) * Encore Medical, L.P., Foundation® Porous Coated (FMP Tm) Acetabular Shells (K(072888) * Smith & Nephew, Inc., R3 Multi-Hole Shells and 36mm XLPE Acetabular Liners (K(0923 86) * Apex Surgical, LL… | 2008 |
| * | K092386 | R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners | 2009 |
| * | K031110 | Apex Modular Acetabular Cup | 2003 |
| * | K062489 | Apex Hcla Acetabular Cup LinersSummary page 2…tabular Liners (K(0923 86) * Apex Surgical, LLC, Apex ModularTm Acetabular Cup (K031 1110) * OMNI Life Science, Inc., Apex HCLATM Acetabular Cup Liners (K062489) * OMNI Life Science, Inc., ApeX-LNK Poly Tm Acetabular Cup Liners (K073 150) INDICATIONS FOR USE The Kiassic HD TmHip Syste… | 2007 |
| * | K073150 | Apex-LNK Poly Acetabular Cup LinersSummary page 2…etabular Cup (K031 1110) * OMNI Life Science, Inc., Apex HCLATM Acetabular Cup Liners (K062489) * OMNI Life Science, Inc., ApeX-LNK Poly Tm Acetabular Cup Liners (K073 150) INDICATIONS FOR USE The Kiassic HD TmHip System is intended for prosthetic replacement without bone cement in treatment of the… | 2008 |
What descends from it? (25)
See all 2512 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143407 | Klassic HD Hip System | 2014 | 16 |
| K141972 | Klassic HD Acetabular Insert with E-Link Poly | 2014 | 14 |
| K161073 | Klassic HD Hip System | 2016 | 6 |
| K180929 | Klassic HD® Hip System | 2018 | 5 |
| K133832 | Klassic HD Hip System, Offset Femoral Stem, Non-Porous / Porous | 2014 | 2 |
| K131454 | Klassic HD (TM) Extended Offset Femoral Head | 2014 | 2 |
| K213580 | Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length | 2021 | 1 |
| K151440 | Klassic HD Hip System | 2015 | 1 |
| K220483 | Platform® Acetabular System | 2022 | 0 |
| K191399 | BIOLOX CONTOURA Ceramic Femoral Head | 2019 | 0 |
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 29 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 13 of the 74 ancestors have a recall of any class.
- Of its descendants, K143407 (Total Joint Othopedics, Inc., 2014) has gone furthest, with 16 descendants of its own.
- 2 other devices also cite its predicate K073068.
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. 2010, 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 Kiassic HDTm 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 painflul 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/K100445 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100445: Klassic HD Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100445
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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