510(k) · Cleared
ClearedMedacta Total Hip Prosthesis System - Line Extension
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Apr 28, 2008 as substantially equivalent to K072857 (Medacta International S.A., 2008) after a 28-day review. Its family tree reaches back 4 generations to 1994. 22 later devices descend from it.
- Decided
- Apr 28, 2008
- Review
- 28 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K932481 (1994). 6 ancestors in all. 22 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
- 3 generations backK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
- 2 generations backK021178 SL-Plus Lateralized StemPlus Orthopedics · 2002
- 1 generation backK072857 Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head +…Medacta International S.A. · 2008 · Recalled
- This deviceK080885 Medacta Total Hip Prosthesis System - Line ExtensionMedacta International S.A. · 2008
- Descendant · cites it directly · 21 of its ownK103721 Mpact Acetabular SystemMedacta International · 2011
- Descendant · 2 generations on · 14 of its ownK122641 Mpact ExtensionMedacta International · 2012
- Descendant · 2 generations on · 11 of its ownK132879 Mpact ExtensionMedacta International · 2014
- Descendant · 2 generations on · 4 of its ownK183582 MPACT ExtensionMedacta International S.A. · 2019
- Descendant · 2 generations on · 3 of its ownK230011 Mpact ExtensionMedacta International S.A. · 2023
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K103721Mpact Acetabular SystemMedacta International · 2011 · cites it directly21descendants
- K122641Mpact ExtensionMedacta International · 2012 · 2 generations on14descendants
- K132879Mpact ExtensionMedacta International · 2014 · 2 generations on11descendants
- K183582MPACT ExtensionMedacta International S.A. · 2019 · 2 generations on4descendants
- K230011Mpact ExtensionMedacta International S.A. · 2023 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932481 | SL-Plus and SLR-Plus | Encore Orthopedics, Inc. | 1994 | — |
| −3 | K001942 | SL-Plus and SLR-Plus Stems | Plus Orthopedics | 2000 | — |
| −2 | K021178 | SL-Plus Lateralized Stem | Plus Orthopedics | 2002 | — |
| −1 | K072857 | Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + Apricot | Medacta International S.A. | 2008 | 1 |
| 0 (this device) | K080885 | Medacta Total Hip Prosthesis System - Line Extension | Medacta International S.A. | 2008 | — |
| +1 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
| +2 | K122641 | Mpact Extension | Medacta International | 2012 | — |
| +2 | K132879 | Mpact Extension | Medacta International | 2014 | — |
| +2 | K183582 | MPACT Extension | Medacta International S.A. | 2019 | — |
| +2 | K230011 | Mpact Extension | Medacta International S.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K072857 | Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + ApricotSummary page 1…ct Code: JDI Predicate Devices: The Medacta Total Hip Prosthesis - Line Extensions are substantially equivalent to the Medacta Total Hip Prosthesis System cleared under K072857 on Feb. 4, 2008. Product Modification: The device modifications to the Medacta Total Hip Prosthesis System which are the subject… | 2008 |
What descends from it? (22)
See all 222 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 14 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K103721 (Medacta International, 2011) has gone furthest, with 21 descendants of its own.
- 5 other devices also cite its predicate K072857.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Medacta Total Hip Prosthesis System is intended for cementless use in total or partial hip arthroplasty and in primary or revision surgery.
Hip replacement is indicated in the following cases:
* Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia
* Avascular necrosis of the femoral head
* Acute traumatic fracture of the femoral head or neck
* Failure bf previous hip surgery, joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080885 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080885: Medacta Total Hip Prosthesis System - Line Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080885
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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