510(k) · Cleared
ClearedMectacer Biolox Forte-Femoral Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Feb 13, 2008 as substantially equivalent to K070928 (Plus Orthopedics AG, 2007) and 1 other predicate after a 77-day review. Its family tree reaches back 3 generations to 2000. 16 later devices descend from it.
- Decided
- Feb 13, 2008
- Review
- 77 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K993736 (2000). 7 ancestors in all, the oldest K914574 (1992). 16 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK993736 Exactech Acumatch Integrated Hip System M-Series Femoral Stem…Exactech, Inc. · 2000 · Recalled
- 2 generations backK010120 Modification to Exactech Acumatch Integrated Hip System, M-Series…Exactech, Inc. · 2001
- 1 generation backK032964 Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series…Exactech, Inc. · 2003 · Recalled
- This deviceK073337 Mectacer Biolox Forte-Femoral HeadsMedacta International S.A. · 2008
- Descendant · cites it directly · 14 of its ownK112115 Mectacer Biolox (R) Delta Femoral HeadsMedacta International · 2011
- Descendant · cites it directly · 8 of its ownK121665 Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012
- Descendant · 2 generations on · 7 of its ownK150007 Modified Bencox Hip SystemCorentec Co., Ltd. · 2015
- Descendant · 3 generations on · 6 of its ownK162127 Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · Recalled
- Descendant · 3 generations on · 4 of its ownK172806 Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International · 2011 · cites it directly14descendants
- K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012 · cites it directly8descendants
- K150007Modified Bencox Hip SystemCorentec Co., Ltd. · 2015 · 2 generations on7descendants
- K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · 3 generations on6descendants
- K172806Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K993736 | Exactech Acumatch Integrated Hip System M-Series Femoral Stem Component | Exactech, Inc. | 2000 | 1 |
| −2 | K010120 | Modification to Exactech Acumatch Integrated Hip System, M-Series High Off-Set… | Exactech, Inc. | 2001 | — |
| −1 | K032964 | Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck… | Exactech, Inc. | 2003 | 1 |
| 0 (this device) | K073337 | Mectacer Biolox Forte-Femoral Heads | Medacta International S.A. | 2008 | — |
| +1 | K112115 | Mectacer Biolox (R) Delta Femoral Heads | Medacta International | 2011 | — |
| +1 | K121665 | Bencox Foret & Bencox Delta | Corentec Co., Ltd. | 2012 | — |
| +2 | K150007 | Modified Bencox Hip System | Corentec Co., Ltd. | 2015 | — |
| +3 | K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | Corentec Co., Ltd. | 2016 | 1 |
| +3 | K172806 | Bencox Mirabo Cup System | Corentec Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K070928 | Ceramic Ball Heads, 28, 32 and 36 MMSummary page 1…duct Code: LZO Predicate Devices: The MectaCer BIOLOX® forte Femoral Heads are substantially equivalent to Plus Ceramic Ball Heads 28, 32 & 36, which were cleared under K070928 and Exactach® 12/14 Alumina Femoral Heads, which were cleared under K032964. Product Description: The MectaCer BIOLOX® forte Fem… | 2007 |
| * | K032964 | Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck SegmentsSummary page 1…are substantially equivalent to Plus Ceramic Ball Heads 28, 32 & 36, which were cleared under K070928 and Exactach® 12/14 Alumina Femoral Heads, which were cleared under K032964. Product Description: The MectaCer BIOLOX® forte Femoral Heads are ceramic ball heads intended for mechanical fixation to a mati… | 2003 |
What descends from it? (16)
See all 163 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 8 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K112115 (Medacta International, 2011) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K070928.
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. 2008, 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 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…
Read the full statement (117 words)
The MectaCer BIOLOX®forte 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 psoriatic 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 as stated in the FDA summary.
https://510kreport.com/device/K073337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073337: Mectacer Biolox Forte-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/K073337
Report an extraction error
Are you the manufacturer?
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