510(k) · Cleared
ClearedModulus Compatible Stability (MCS)-HA Total Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Feb 4, 1999 after a 15-day review. The FDA summary names its predicate without a number. 164 later devices descend from it.
- Decided
- Feb 4, 1999
- Review
- 15 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 0
164 later devices descend from it, 5 citing it directly.
- This deviceK990197 Modulus Compatible Stability (MCS)-HA Total Hip SystemExactech, Inc. · 1999
- Descendant · cites it directly · 161 of its ownK993082 Exactech Acumatch Integrated Hip System a-Series Porous Coated…Exactech, Inc. · 1999 · Recalled
- Descendant · cites it directly · 147 of its ownK002141 Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit…Exactech, Inc. · 2000
- Descendant · cites it directly · 146 of its ownK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- Descendant · 2 generations on · 145 of its ownK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 64 of its ownK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
Showing 5 of 164 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 164 · See all- K993082Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular ComponentExactech, Inc. · 1999 · cites it directly161descendants
- K002141Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit, Acumatch L-Series…Exactech, Inc. · 2000 · cites it directly147descendants
- K030236Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003 · cites it directly146descendants
- K041906Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · 2 generations on145descendants
- K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004 · 3 generations on64descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990197 | Modulus Compatible Stability (MCS)-HA Total Hip System | Exactech, Inc. | 1999 | — |
| +1 | K993082 | Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular… | Exactech, Inc. | 1999 | 2 |
| +1 | K002141 | Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit, Acumatch… | Exactech, Inc. | 2000 | — |
| +1 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| +2 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| +3 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 8 | 0 |
| 2013 | 5 | 0 |
| 2014 | 9 | 0 |
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2017 | 8 | 0 |
| 2018 | 8 | 0 |
| 2019 | 14 | 0 |
| 2020 | 6 | 0 |
| 2021 | 7 | 0 |
| 2022 | 11 | 0 |
| 2023 | 13 | 0 |
| 2024 | 13 | 0 |
| 2025 | 17 | 0 |
| 2026 | 14 | 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 MEH? 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | — | Exactech MCS Total Hip System Named without a submission number | |
| * | — | Charnley Named without a submission number | |
| * | — | Zimmer Harris-Galante Named without a submission number | |
| * | — | Depuy AML Named without a submission number | |
| * | — | Osteonics Secur-Fit HA Named without a submission number | |
| * | — | Smith & Nephew Synergy HA Named without a submission number | |
| * | — | OTI Named without a submission number |
What descends from it? (164)
See all 1645 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993082 | Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular Component | 1999 | 161 |
| K002141 | Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit, Acumatch L-Series… | 2000 | 147 |
| K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | 2003 | 146 |
| K040613 | Exactech Acumatch a-Series and MCS Acetabular Shells and Liners | 2004 | 61 |
| K080980 | Exactech Novation Element Press-Fit Femoral Stems | 2008 | 28 |
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?
- Of its descendants, K993082 (Exactech, Inc., 1999) has gone furthest, with 161 descendants of its own.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis. ankylosing spondylitis, congenital hip dysplasia, 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. Exactech Hip Systems are also potentially indicated for revision of failed previous reconstruction’s 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/K990197 · printed Nov 3, 2026
Cite this page
510(k) Report. “K990197: Modulus Compatible Stability (MCS)-HA Total Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K990197
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