510(k) · Cleared
ClearedMectacer Biolox (R) Delta Femoral Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Oct 7, 2011 as substantially equivalent to K073337 (Medacta International S.A., 2008) and 3 other predicates after a 74-day review. Its family tree reaches back 9 generations to 1981. 14 later devices descend from it.
- Decided
- Oct 7, 2011
- Review
- 74 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K810258 (1981). 47 ancestors in all. 14 later devices descend from it, 5 citing it directly.
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 5 generations between
- 3 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 2 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 1 generation backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- This deviceK112115 Mectacer Biolox (R) Delta Femoral HeadsMedacta International · 2011
- Descendant · cites it directly · 7 of its ownK150007 Modified Bencox Hip SystemCorentec Co., Ltd. · 2015
- Descendant · 2 generations on · 6 of its ownK162127 Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · Recalled
- Descendant · 2 generations on · 4 of its ownK172806 Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017
- Descendant · 3 generations on · 3 of its ownK182221 Bencox Mirabo Cup Multi HoleCorentec Co., Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK160895 Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation · 2016
Show all 9 generations
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 7 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 6 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 5 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 4 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 3 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 2 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 1 generation backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- This deviceK112115 Mectacer Biolox (R) Delta Femoral HeadsMedacta International · 2011
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K150007Modified Bencox Hip SystemCorentec Co., Ltd. · 2015 · cites it directly7descendants
- K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · 2 generations on6descendants
- K172806Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017 · 2 generations on4descendants
- K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd. · 2019 · 3 generations on3descendants
- K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation · 2016 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −8 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −7 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −6 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −5 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −4 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −3 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −2 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −1 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| 0 (this device) | K112115 | Mectacer Biolox (R) Delta Femoral Heads | Medacta International | 2011 | — |
| +1 | K150007 | Modified Bencox Hip System | Corentec Co., Ltd. | 2015 | — |
| +2 | K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | Corentec Co., Ltd. | 2016 | 1 |
| +2 | K172806 | Bencox Mirabo Cup System | Corentec Co., Ltd. | 2017 | — |
| +3 | K182221 | Bencox Mirabo Cup Multi Hole | Corentec Co., Ltd. | 2019 | — |
| +1 | K160895 | Initia Total Hip System & BIOCERAM AZUL (R) HEAD | Kyocera Medical Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K073337 | Mectacer Biolox Forte-Femoral HeadsSummary page 1…p Joint, metalI/ce ram ic/po lymer, semniconstrained, cemented or non-porous uncemented prosthesis 21 CFR 888.3353 Class 11 Device Product Code: LZO Predicate Devices: K073337 Medacta MectaCer BIOLOX®O forte Femoral Heads K071 535 Zimmer BIOLOX delta Ceramic Femoral Head K083762 Smith & Nephew Biolox Del… | 2008 |
| * | K071535 | Biolox Delta Ceramic Femoral HeadSummary page 1…cemented or non-porous uncemented prosthesis 21 CFR 888.3353 Class 11 Device Product Code: LZO Predicate Devices: K073337 Medacta MectaCer BIOLOX®O forte Femoral Heads K071 535 Zimmer BIOLOX delta Ceramic Femoral Head K083762 Smith & Nephew Biolox Delta Ceramic Femoral Heads K1 00412 Smith & Nephew Biolox… | 2007 |
| * | K083762 | Biolox Delta Ceramic Femoral HeadsSummary page 1…FR 888.3353 Class 11 Device Product Code: LZO Predicate Devices: K073337 Medacta MectaCer BIOLOX®O forte Femoral Heads K071 535 Zimmer BIOLOX delta Ceramic Femoral Head K083762 Smith & Nephew Biolox Delta Ceramic Femoral Heads K1 00412 Smith & Nephew Biolox Delta Ceramic Femoral Heads - large sizes Me… | 2009 |
| * | K100412 | Biolox Delta Ceramic Femoral HeadsSummary page 1…evices: K073337 Medacta MectaCer BIOLOX®O forte Femoral Heads K071 535 Zimmer BIOLOX delta Ceramic Femoral Head K083762 Smith & Nephew Biolox Delta Ceramic Femoral Heads K1 00412 Smith & Nephew Biolox Delta Ceramic Femoral Heads - large sizes Mectacer Biolox Delta Heads 510(k)… | 2010 |
What descends from it? (14)
See all 145 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 30 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 13 of the 47 ancestors have a recall of any class.
- Of its descendants, K150007 (Corentec Co., Ltd., 2015) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K073337.
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. 2011, 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 MectaCer BIOLOX® forte femoral heads and the MectaCer BIOLOX® delta femoral heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for total or partial hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patient's condition should be due to one or more of the following: * Severely painful and/or disabled joint as a result of osteoarthritis…
Read the full statement (129 words)
The MectaCer BIOLOX® forte femoral heads and the MectaCer BIOLOX® delta femoral heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for total or partial hip arthroplasty in primary or revision surgery.
The patient should be skeletally mature.
The patient's condition should be due to one or more of the following:
* Severely painful and/or disabled joint as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or psoriadic arthritis,
* Congenital hip dysplasia,
* Ankylosing spondylitis,
* Avascular necrosis of the femoral head,
* Acute traumatic fracture of the femoral head or neck,
* Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement where sufficient bone stock is present.
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/K112115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112115: Mectacer Biolox (R) Delta Femoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112115
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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