510(k) · Cleared
Recalled · Class II · 2012Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + Apricot
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 Feb 4, 2008 as substantially equivalent to K001942 (Plus Orthopedics, 2000) and 3 other predicates after a 122-day review. Its family tree reaches back 3 generations to 1994. 39 later devices descend from it. It has been recalled once.
- Decided
- Feb 4, 2008
- Review
- 122 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 3 generations to K932481 (1994). 5 ancestors in all. 39 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
- 2 generations backK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
- 1 generation backK021178 SL-Plus Lateralized StemPlus Orthopedics · 2002
- This deviceK072857 Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head +…Medacta International S.A. · 2008
- Descendant · cites it directly · 22 of its ownK080885 Medacta Total Hip Prosthesis System - Line ExtensionMedacta International S.A. · 2008
- Descendant · 2 generations on · 21 of its ownK103721 Mpact Acetabular SystemMedacta International · 2011
- Descendant · 3 generations on · 14 of its ownK122641 Mpact ExtensionMedacta International · 2012
- Descendant · cites it directly · 12 of its ownK093944 Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra SMedacta International S.A. · 2010 · Recalled
- Descendant · 3 generations on · 11 of its ownK132879 Mpact ExtensionMedacta International · 2014
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K080885Medacta Total Hip Prosthesis System - Line ExtensionMedacta International S.A. · 2008 · cites it directly22descendants
- K103721Mpact Acetabular SystemMedacta International · 2011 · 2 generations on21descendants
- K122641Mpact ExtensionMedacta International · 2012 · 3 generations on14descendants
- K093944Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra SMedacta International S.A. · 2010 · cites it directly12descendants
- K132879Mpact ExtensionMedacta International · 2014 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932481 | SL-Plus and SLR-Plus | Encore Orthopedics, Inc. | 1994 | — |
| −2 | K001942 | SL-Plus and SLR-Plus Stems | Plus Orthopedics | 2000 | — |
| −1 | K021178 | SL-Plus Lateralized Stem | Plus Orthopedics | 2002 | — |
| 0 (this device) | K072857 | Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + Apricot | Medacta International S.A. | 2008 | — |
| +1 | K080885 | Medacta Total Hip Prosthesis System - Line Extension | Medacta International S.A. | 2008 | — |
| +2 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
| +3 | K122641 | Mpact Extension | Medacta International | 2012 | — |
| +1 | K093944 | Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra S | Medacta International S.A. | 2010 | 1 |
| +3 | K132879 | Mpact Extension | Medacta International | 2014 | — |
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 |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 5 | 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? (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 |
|---|---|---|---|
| * | K001942 | SL-Plus and SLR-Plus StemsSummary page 1…osthesis Predicate Device /Manufacturer K# System Component Quadra® S SL-PLUS® and SLR-PLUS® Stems, Plus K001942 Orthopedics AG SL-PLUS® Lateralized Stem, Plus orthopedics K0… | 2000 |
| * | K021178 | SL-Plus Lateralized StemSummary page 1…SLR-PLUS® Stems, Plus K001942 Orthopedics AG SL-PLUS® Lateralized Stem, Plus orthopedics K021178 AG CoCrMo Femoral Ball Portland Cobalt Chrome Femoral Head, Portland K063278… | 2002 |
| * | K063278 | Portland Cobalt Chrome Femoral HeadSummary page 1…L-PLUS® Lateralized Stem, Plus orthopedics K021178 AG CoCrMo Femoral Ball Portland Cobalt Chrome Femoral Head, Portland K063278 Head Orthopaedics, Ltd. Ko1 5… | 2007 |
| * | K042565 | Encompass Hip Stem, Tri-Plus Acetabular Shell, Tri-Plus DCM LinerSummary page 2…s Predicate Device /Manufacturer K# System Component Tri-PlusTM Cup System Not applicable, previously cleared acetabular K042565 cups and liners 4) Device Description The components of the Medacta Total Hip Prosthesis Sys… | 2005 |
What descends from it? (39)
See all 396 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080885 | Medacta Total Hip Prosthesis System - Line Extension | 2008 | 22 |
| K093944 | Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra S | 2010 | 12 |
| K082792 | Medacta Total Hip Prosthesis System - Quadra H and R Femoral Stems | 2008 | 11 |
| K121011 | Amistem and Quadra - Line Extension | 2012 | 10 |
| K083558 | Medacta Total Hip Prosthesis System - Quadra C | 2009 | 9 |
| K111145 | Endo Head | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 17, 2012 | Class II | Z-0791-2013 | Device Design | The tip of the Quadra Trial Broach size 0, broke during a surgery. |
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.
- None of the 5 ancestors has a recall.
- Of its descendants, K080885 (Medacta International S.A., 2008) has gone furthest, with 22 descendants of its own.
- 8 other devices also cite its predicate K001942.
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 of 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/K072857 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072857: Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + Apricot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072857
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