510(k) · Cleared
Recalled · Class II · 2022Exactech Acumatch a-Series & MCS Constrained Acetabular Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Cleared on Oct 4, 2004 as substantially equivalent to K993082 (Exactech, Inc., 1999) and 3 other predicates after a 210-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 4, 2004
- Review
- 210 days
- Class
- Class II
- Product code
- KWZ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 3 generations to P960047 (1997). 10 ancestors in all, the oldest K921114 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backP960047 Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp. · 1997
- 2 generations backK021661 Ringloc Constrained LinersBiomet Orthopedics, Inc. · 2002
- 1 generation backK030923 Epsilon Durasul Constrained Acetabular LinerCenterpulse Orthopedics, Inc. · 2003
- This deviceK040601 Exactech Acumatch a-Series & MCS Constrained Acetabular LinersExactech, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK071676 Exactech Novation Crown Cup Constrained Liners and RingsExactech, Inc. · 2007 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K071676Exactech Novation Crown Cup Constrained Liners and RingsExactech, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P960047 | Osteonics Constrained Acetabular Insert | Howmedica Osteonics Corp. | 1997 | — |
| −2 | K021661 | Ringloc Constrained Liners | Biomet Orthopedics, Inc. | 2002 | — |
| −1 | K030923 | Epsilon Durasul Constrained Acetabular Liner | Centerpulse Orthopedics, Inc. | 2003 | — |
| 0 (this device) | K040601 | Exactech Acumatch a-Series & MCS Constrained Acetabular Liners | Exactech, Inc. | 2004 | — |
| +1 | K071676 | Exactech Novation Crown Cup Constrained Liners and Rings | Exactech, Inc. | 2007 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 KWZ? 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 KWZ device
- #1 K241461 Mpact Constrained Linerscore 15.5 · 10 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K993082 | Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular ComponentSummary page 3…K040601 - Page 3 of 3 Exactech AcuMatch A-Series ~ & MCS ® Constrained Acetabular Liners The devices are identical to previously cleared Exactech AcuMatch® (K993082) and MCS®(K921114) Liners except for the femoral head constraining features. The devices are similar to the Ringloc Constrained L… | 1999 |
| * | K921114 | Exactech MCS Porous Coated Total Hip AcetabularSummary page 3…Page 3 of 3 Exactech AcuMatch A-Series ~ & MCS ® Constrained Acetabular Liners The devices are identical to previously cleared Exactech AcuMatch® (K993082) and MCS®(K921114) Liners except for the femoral head constraining features. The devices are similar to the Ringloc Constrained Liner (K021728) fro… | 1993 |
| * | K021728 | Ringloc Constrained Liners IISummary page 3…leared Exactech AcuMatch® (K993082) and MCS®(K921114) Liners except for the femoral head constraining features. The devices are similar to the Ringloc Constrained Liner (K021728) from Biomet Orthopedics and the Epsilon Durasul Constrained Acetabular Liner (K030923) from Centerpulse Orthopedics. Performan… | 2002 |
| * | K030923 | Epsilon Durasul Constrained Acetabular LinerSummary page 3…d constraining features. The devices are similar to the Ringloc Constrained Liner (K021728) from Biomet Orthopedics and the Epsilon Durasul Constrained Acetabular Liner (K030923) from Centerpulse Orthopedics. Performance Testing: The Exactech AcuMatch A-Series® Constrained Acetabular Liner & MCS®… | 2003 |
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 |
|---|---|---|---|
| K071676 | Exactech Novation Crown Cup Constrained Liners and Rings | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 11, 2022 | Class II | Z-1725-2022 | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K071676 (Exactech, Inc., 2007) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K993082.
How does its category compare?
All KWZ devicesKWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWZ
104in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWZ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWZ
193in 2025
MAUDE reports naming product code KWZ, 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 | 7 | 104 | 0 | 41 |
| 2008 | 1 | — | 0 | 44 |
| 2009 | 1 | — | 0 | 81 |
| 2010 | 1 | — | 8 | 98 |
| 2011 | 1 | — | 0 | 127 |
| 2012 | 1 | — | 1 | 168 |
| 2013 | 0 | — | 0 | 274 |
| 2014 | 0 | — | 0 | 278 |
| 2015 | 0 | — | 0 | 636 |
| 2016 | 1 | — | 0 | 1,180 |
| 2017 | 2 | — | 0 | 477 |
| 2018 | 0 | — | 0 | 283 |
| 2019 | 0 | — | 0 | 532 |
| 2020 | 0 | — | 0 | 288 |
| 2021 | 0 | — | 0 | 216 |
| 2022 | 0 | — | 0 | 158 |
| 2023 | 0 | — | 1 | 164 |
| 2024 | 1 | — | 0 | 145 |
| 2025 | 1 | — | 0 | 193 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Exactech AcuMatch A-Series® and MCS® Constrained Acetabular Liners are compoients of the Exactech AcuMatch A-Series or MCS non-cemented acetabular cup system. The device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. They are intended for press-fit fixation and compatible with Exactech press-fit or cemented femoral stem components.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040601 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040601: Exactech Acumatch a-Series & MCS Constrained Acetabular Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040601
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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