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 Othopedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Oct 19, 2016 as substantially equivalent to K100445 (Total Joint Orthopedics, Inc., 2010) and 1 other predicate after a 184-day review. Its family tree reaches back 10 generations to 1981. 6 later devices descend from it.
- Decided
- Oct 19, 2016
- Review
- 184 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K810258 (1981). 122 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 6 generations between
- 3 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 2 generations backK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
- 1 generation backK141972 Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
- This deviceK161073 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK180929 Klassic HD® Hip SystemTotal Joint Orthopedics, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK213580 Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK243809 Biolox® Delta Revision headsLimacorporate · 2025
- Descendant · 2 generations on · 0 of its ownK221675 United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK220483 Platform® Acetabular SystemTotal Joint Orthopedics, Inc. · 2022
Show all 10 generations
- Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 9 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 8 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 7 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 6 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 5 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 4 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 3 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 2 generations backK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
- 1 generation backK141972 Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
- This deviceK161073 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc. · 2018 · cites it directly5descendants
- K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc. · 2021 · 2 generations on1descendant
- K243809Biolox® Delta Revision headsLimacorporate · 2025 · 3 generations on0descendants
- K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation · 2022 · 2 generations on0descendants
- K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −9 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −8 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −7 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −6 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −5 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −4 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −3 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −2 | K100445 | Klassic HD Hip System | Total Joint Orthopedics, Inc. | 2010 | — |
| −1 | K141972 | Klassic HD Acetabular Insert with E-Link Poly | Total Joint Orthopedics, Inc. | 2014 | — |
| 0 (this device) | K161073 | Klassic HD Hip System | Total Joint Othopedics, Inc. | 2016 | — |
| +1 | K180929 | Klassic HD® Hip System | Total Joint Orthopedics, Inc. | 2018 | — |
| +2 | K213580 | Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length | Total Joint Othopedics, Inc. | 2021 | — |
| +3 | K243809 | Biolox® Delta Revision heads | Limacorporate | 2025 | — |
| +2 | K221675 | United U2 femoral head, 22mm delta ceramic head | United Orthopedic Corporation | 2022 | — |
| +2 | K220483 | Platform® Acetabular System | Total Joint Orthopedics, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 3 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 5 | 0 |
| 1994 | 17 | 0 |
| 1995 | 8 | 0 |
| 1996 | 8 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 8 | 0 |
| 2000 | 11 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2025 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K100445 | Klassic HD Hip SystemSummary page 5…tion. The Insert with XLPE is sterilized by ethylene oxide gas and intended for single-use only. Predicate Devices: Total Joint Orthopedics Klassic HD® Hip System (K100445, K141972) Reference Devices: Ortho Development Corporation Escalade Acetabular Cup System (K103384) Wright Medical Tech… | 2010 |
| * | K141972 | Klassic HD Acetabular Insert with E-Link PolySummary page 5…Insert with XLPE is sterilized by ethylene oxide gas and intended for single-use only. Predicate Devices: Total Joint Orthopedics Klassic HD® Hip System (K100445, K141972) Reference Devices: Ortho Development Corporation Escalade Acetabular Cup System (K103384) Wright Medical Technology, I… | 2014 |
| † | K103384 | Escalade Acetabular Cup System | 2011 |
| † | K052026 | Lineage a-Class Poly Liner | 2005 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180929 | Klassic HD® Hip System | 2018 | 5 |
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 35 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 21 of the 122 ancestors have a recall of any class.
- Of its descendants, K180929 (Total Joint Orthopedics, Inc., 2018) has gone furthest, with 5 descendants 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. 2016, 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® 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161073 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161073: Klassic HD Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161073
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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