510(k) · Cleared
ClearedAdapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Total Joint Othopedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Dec 3, 2021 as substantially equivalent to K180929 (Total Joint Orthopedics, Inc., 2018) and 2 other predicates after a 23-day review. Its family tree reaches back 12 generations to 1981. 1 later device descends from it.
- Decided
- Dec 3, 2021
- Review
- 23 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K810258 (1981). 126 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK213580 Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK243809 Biolox® Delta Revision headsLimacorporate · 2025
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 deviceK213580 Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K243809Biolox® Delta Revision headsLimacorporate · 2025 · cites it directly0descendants
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) | K213580 | Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length | Total Joint Othopedics, Inc. | 2021 | — |
| +1 | K243809 | Biolox® Delta Revision heads | Limacorporate | 2025 | — |
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 |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K180929 | Klassic HD® Hip SystemSummary page 5…rovided sterile, for single use, by prescription only. Predicate Devices: The modified Klassic HD® Hip System is substantially equivalent to the Klassic HD® Hip System (K180929, K143407, K100445) with respect to indications, design, materials, and function. The information summarized in the Design Control… | 2018 |
| * | K143407 | Klassic HD Hip SystemSummary page 5…offsets (K100445). The subject device is fabricated from Ti6Al4V per ASTM F136. The subject device is compatible with 32mm and 36mm BIOLOX® OPTION Ceramic Femoral Heads (K143407), and also compatible with the Klassic HD® Femoral Stems (K100445) and the Klassic Blade Femoral Stems (K151440 and K171962). The… | 2014 |
| * | K100445 | Klassic HD Hip SystemSummary page 5…echanics intra-operatively. The +10.5mm offset option for the Femoral Head Adapter Sleeves is a line extension to the currently available predicate adapter head offsets (K100445). The subject device is fabricated from Ti6Al4V per ASTM F136. The subject device is compatible with 32mm and 36mm BIOLOX® OPTION… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243809 | Biolox® Delta Revision heads | 2025 | 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 40 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.
- Of its descendants, K243809 (Limacorporate, 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K180929.
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. 2021, 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 as stated in the FDA summary.
https://510kreport.com/device/K213580 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213580: Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213580
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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