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. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on May 9, 2018 as substantially equivalent to K100445 (Total Joint Orthopedics, Inc., 2010) and 4 other predicates after a 30-day review. Its family tree reaches back 11 generations to 1981. 5 later devices descend from it.
- Decided
- May 9, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K810258 (1981). 125 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations between
- 3 generations backK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
- 2 generations backK141972 Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
- 1 generation backK161073 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2016
- This deviceK180929 Klassic HD® Hip SystemTotal Joint Orthopedics, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK213580 Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK243809 Biolox® Delta Revision headsLimacorporate · 2025
- Descendant · cites it directly · 0 of its ownK221675 United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation · 2022
- Descendant · cites it directly · 0 of its ownK220483 Platform® Acetabular SystemTotal Joint Orthopedics, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK191399 BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc. · 2019
Show all 11 generations
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 9 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 8 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 7 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 6 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 5 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 4 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 3 generations backK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
- 2 generations backK141972 Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
- 1 generation backK161073 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2016
- This deviceK180929 Klassic HD® Hip SystemTotal Joint Orthopedics, Inc. · 2018
Most influential descendants
Showing 5 of 5 · See all- K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc. · 2021 · cites it directly1descendant
- K243809Biolox® Delta Revision headsLimacorporate · 2025 · 2 generations on0descendants
- K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation · 2022 · cites it directly0descendants
- K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc. · 2022 · cites it directly0descendants
- K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −10 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −9 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −8 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −7 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −6 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −5 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −4 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −3 | K100445 | Klassic HD Hip System | Total Joint Orthopedics, Inc. | 2010 | — |
| −2 | K141972 | Klassic HD Acetabular Insert with E-Link Poly | Total Joint Orthopedics, Inc. | 2014 | — |
| −1 | K161073 | Klassic HD Hip System | Total Joint Othopedics, Inc. | 2016 | — |
| 0 (this device) | K180929 | Klassic HD® Hip System | Total Joint Orthopedics, Inc. | 2018 | — |
| +1 | K213580 | Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length | Total Joint Othopedics, Inc. | 2021 | — |
| +2 | K243809 | Biolox® Delta Revision heads | Limacorporate | 2025 | — |
| +1 | K221675 | United U2 femoral head, 22mm delta ceramic head | United Orthopedic Corporation | 2022 | — |
| +1 | K220483 | Platform® Acetabular System | Total Joint Orthopedics, Inc. | 2022 | — |
| +1 | K191399 | BIOLOX CONTOURA Ceramic Femoral Head | Total Joint Othopedics, Inc. | 2019 | — |
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 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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…XLPE material. Predicate Devices: The modified Klassic HD® Hip System is substantially equivalent to the predicate Klassic HD® Hip System Acetabular Cups with Ti-Coat (K100445), Klassic HD® Acetabular Inserts with E-Link® Poly (K141972), Klassic HD® Acetabular Inserts with XLPE (K161073), Klassic HD® Cer… | 2010 |
| * | K141972 | Klassic HD Acetabular Insert with E-Link PolySummary page 5…Hip System is substantially equivalent to the predicate Klassic HD® Hip System Acetabular Cups with Ti-Coat (K100445), Klassic HD® Acetabular Inserts with E-Link® Poly (K141972), Klassic HD® Acetabular Inserts with XLPE (K161073), Klassic HD® Ceramic Femoral Heads (K143407) and the Klassic HD® Hooded and… | 2014 |
| * | K161073 | Klassic HD Hip SystemSummary page 5…cate Klassic HD® Hip System Acetabular Cups with Ti-Coat (K100445), Klassic HD® Acetabular Inserts with E-Link® Poly (K141972), Klassic HD® Acetabular Inserts with XLPE (K161073), Klassic HD® Ceramic Femoral Heads (K143407) and the Klassic HD® Hooded and Low Profile Acetabular Inserts with E-Link® Poly (K1… | 2016 |
| * | K143407 | Klassic HD Hip SystemSummary page 5…ith Ti-Coat (K100445), Klassic HD® Acetabular Inserts with E-Link® Poly (K141972), Klassic HD® Acetabular Inserts with XLPE (K161073), Klassic HD® Ceramic Femoral Heads (K143407) and the Klassic HD® Hooded and Low Profile Acetabular Inserts with E-Link® Poly (K173104) with respect to indications, design, m… | 2014 |
| * | K173104 | Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Summary page 5…HD® Acetabular Inserts with XLPE (K161073), Klassic HD® Ceramic Femoral Heads (K143407) and the Klassic HD® Hooded and Low Profile Acetabular Inserts with E-Link® Poly (K173104) with respect to indications, design, materials and function. Substantial Equivalence: Engineering analysis and testing included… | 2017 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 37 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 21 of the 125 ancestors have a recall of any class.
- Of its descendants, K213580 (Total Joint Othopedics, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 11 other devices also cite its predicate K100445.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
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 (1JD): 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/K180929 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180929: Klassic HD® Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180929
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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