510(k) · Cleared
ClearedAcumatch M-Series LPB 12/14 Femoral Stem
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 Dec 1, 2005 as substantially equivalent to K993736 (Exactech, Inc., 2000) and 2 other predicates after a 146-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Dec 1, 2005
- Review
- 146 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K993736 (2000). 6 ancestors in all, the oldest K914574 (1992). No later device cites it as a predicate yet.
- 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 deviceK051858 Acumatch M-Series LPB 12/14 Femoral StemExactech, Inc. · 2005
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) | K051858 | Acumatch M-Series LPB 12/14 Femoral Stem | Exactech, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K993736 | Exactech Acumatch Integrated Hip System M-Series Femoral Stem ComponentSummary page 2…Information on 'devices hi which substanitS1 egqiivalence is claimed. 510(k) Trade or Proprietary or Model Name I Manufacturer Number #K993736 AcuMatch M-Series Femoral Stem Exactech, Inc. (S, M, L metaphyseal, calcar &… | 2000 |
| * | K011081 | Acumatch M-Series Extra-Small Metaphyseal SegmentsSummary page 3…PB 12/14 Femoral Stems are substantially equivalent to the predicate AcuI4vatch M-Serics 12/14 Femoral Stem components cleared through premarket notifications #K993736, #K011081 and #K032964. rev. 11/30/05 Section 4… | 2001 |
| * | K032964 | Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck SegmentsSummary page 2…hyseal, calcar & distal segments) #K01'1081 AcuMatch M-Series Femoral Stem Exactech, Inc. (XS metaphyseal segments) #1K032964 AcuMatch M-Series Femoral Stem Exactech, Inc. ___________(12/14 necksegments)… | 2003 |
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 5 years and passes through 1 company; a new generation was cleared every 2.1 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K993736.
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.
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 (99 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.
AcuMatch M-Series LPB 12/14 Femoral Stems are intended to be used in press-fit and
cemented applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051858: Acumatch M-Series LPB 12/14 Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051858
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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