510(k) · Cleared
ClearedExactech Bioloxdelta / Biolox Femoral Heads, 28MM OD, 32MM OD, 36MM OD, Exactech Biolox Option Adapters/Femoral Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Nov 10, 2010 as substantially equivalent to K032964 (Exactech, Inc., 2003) and 1 other predicate after a 29-day review. Its family tree reaches back 4 generations to 2000. 5 later devices descend from it.
- Decided
- Nov 10, 2010
- Review
- 29 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K993736 (2000). 6 ancestors in all, the oldest K914574 (1992). 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK993736 Exactech Acumatch Integrated Hip System M-Series Femoral Stem…Exactech, Inc. · 2000 · Recalled
- 3 generations backK010120 Modification to Exactech Acumatch Integrated Hip System, M-Series…Exactech, Inc. · 2001
- 2 generations backK032964 Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series…Exactech, Inc. · 2003 · Recalled
- 1 generation backK051682 Exactech 12/14 Alumina Femoral Heads 36 MMExactech, Inc. · 2005
- This deviceK103012 Exactech Bioloxdelta / Biolox Femoral Heads, 28MM OD, 32MM OD, 36MM…Exactech, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK121392 Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10…Exactech, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 3 of its ownK173583 Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 2 of its ownK182502 Alteon Acetabular Cup SystemExactech, Inc. · 2019 · Recalled
- Descendant · 4 generations on · 1 of its ownK210614 BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2022
- Descendant · 5 generations on · 0 of its ownK223223 BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K121392Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 DegreeExactech, Inc. · 2013 · cites it directly4descendants
- K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc. · 2018 · 2 generations on3descendants
- K182502Alteon Acetabular Cup SystemExactech, Inc. · 2019 · 3 generations on2descendants
- K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2022 · 4 generations on1descendant
- K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K993736 | Exactech Acumatch Integrated Hip System M-Series Femoral Stem Component | Exactech, Inc. | 2000 | 1 |
| −3 | K010120 | Modification to Exactech Acumatch Integrated Hip System, M-Series High Off-Set… | Exactech, Inc. | 2001 | — |
| −2 | K032964 | Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck… | Exactech, Inc. | 2003 | 1 |
| −1 | K051682 | Exactech 12/14 Alumina Femoral Heads 36 MM | Exactech, Inc. | 2005 | — |
| 0 (this device) | K103012 | Exactech Bioloxdelta / Biolox Femoral Heads, 28MM OD, 32MM OD, 36MM OD… | Exactech, Inc. | 2010 | — |
| +1 | K121392 | Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 Degree | Exactech, Inc. | 2013 | 7 |
| +2 | K173583 | Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners | Exactech, Inc. | 2018 | 3 |
| +3 | K182502 | Alteon Acetabular Cup System | Exactech, Inc. | 2019 | 2 |
| +4 | K210614 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | 2022 | — |
| +5 | K223223 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K032964 | Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck SegmentsSummary page 1…arketed Devices to Which Substantial Equivalence Is Claimed: 510(kM Number Trade of Proprietary Model Name Manufacturer K032964 Exactech 12/14 Alumina Femoral Heads Exactech, Inc K051682 Exactech 12/… | 2003 |
| * | K051682 | Exactech 12/14 Alumina Femoral Heads 36 MMSummary page 1…e of Proprietary Model Name Manufacturer K032964 Exactech 12/14 Alumina Femoral Heads Exactech, Inc K051682 Exactech 12/14 Alumina Femoral Heads 36mm Exactech, Inc IV. Indications for Use: All E… | 2005 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121392 | Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 Degree | 2013 | 4 |
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 10 years and passes through 1 company; a new generation was cleared every 2.8 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K121392 (Exactech, Inc., 2013) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K032964.
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. 2010, 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?
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing…
Read the full statement (142 words)
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
* Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
* Press-fit femoral stems and acetabular cups are intended for press-fit fixation. Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon
* Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103012: Exactech Bioloxdelta / Biolox Femoral Heads, 28MM OD, 32MM OD, 36MM OD, Exactech Biolox Option Adapters/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/K103012
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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