510(k) · Cleared
ClearedPlatform® Acetabular 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 Sep 23, 2022 as substantially equivalent to K100445 (Total Joint Orthopedics, Inc., 2010) and 3 other predicates after a 217-day review. Its family tree reaches back 12 generations to 1981.
- Decided
- Sep 23, 2022
- Review
- 217 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K810258 (1981). 126 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations between
- 3 generations backK141972 Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
- 2 generations backK161073 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2016
- 1 generation backK180929 Klassic HD® Hip SystemTotal Joint Orthopedics, Inc. · 2018
- This deviceK220483 Platform® Acetabular SystemTotal Joint Orthopedics, Inc. · 2022
Show all 12 generations
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 11 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 10 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 9 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 8 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 7 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 6 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 5 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 4 generations backK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
- 3 generations backK141972 Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
- 2 generations backK161073 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2016
- 1 generation backK180929 Klassic HD® Hip SystemTotal Joint Orthopedics, Inc. · 2018
- This deviceK220483 Platform® Acetabular SystemTotal Joint Orthopedics, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −11 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −10 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −9 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −8 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −7 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −6 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −5 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −4 | K100445 | Klassic HD Hip System | Total Joint Orthopedics, Inc. | 2010 | — |
| −3 | K141972 | Klassic HD Acetabular Insert with E-Link Poly | Total Joint Orthopedics, Inc. | 2014 | — |
| −2 | K161073 | Klassic HD Hip System | Total Joint Othopedics, Inc. | 2016 | — |
| −1 | K180929 | Klassic HD® Hip System | Total Joint Orthopedics, Inc. | 2018 | — |
| 0 (this device) | 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 |
| 2014 | 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 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? (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 5…use, by prescription only. Predicate Devices: The modified Klassic HD Hip System is substantially equivalent to the predicate Klassic HD® Hip System (Primary predicate: K100445; Additional predicates: K141972, K173104, K180929) with respect to indications, design, material and function. The information su… | 2010 |
| * | K141972 | Klassic HD Acetabular Insert with E-Link PolySummary page 5…icate Devices: The modified Klassic HD Hip System is substantially equivalent to the predicate Klassic HD® Hip System (Primary predicate: K100445; Additional predicates: K141972, K173104, K180929) with respect to indications, design, material and function. The information summarized in this 510(k) demonstr… | 2014 |
| * | K173104 | Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Summary page 5…ices: The modified Klassic HD Hip System is substantially equivalent to the predicate Klassic HD® Hip System (Primary predicate: K100445; Additional predicates: K141972, K173104, K180929) with respect to indications, design, material and function. The information summarized in this 510(k) demonstrates that… | 2017 |
| * | K180929 | Klassic HD® Hip SystemSummary page 5…modified Klassic HD Hip System is substantially equivalent to the predicate Klassic HD® Hip System (Primary predicate: K100445; Additional predicates: K141972, K173104, K180929) with respect to indications, design, material and function. The information summarized in this 510(k) demonstrates that the subj… | 2018 |
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 41 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 21 of the 126 ancestors have a recall of any class.
- 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. 2022, 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 (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/K220483 · printed Nov 5, 2026
Cite this page
510(k) Report. “K220483: Platform® Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K220483
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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