510(k) · Cleared
ClearedSC Total Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopedic Alliance, LLC · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Oct 15, 2003 after a 159-day review. The FDA summary names its predicate without a number. 200 later devices descend from it.
- Decided
- Oct 15, 2003
- Review
- 159 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
200 later devices descend from it, 2 citing it directly.
- This deviceK031474 SC Total Hip SystemOrthopedic Alliance, LLC · 2003
- Descendant · cites it directly · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 90 of its ownK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- Descendant · 2 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- Descendant · 2 generations on · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- Descendant · 2 generations on · 79 of its ownK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
Showing 5 of 200 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 200 · See all- K042344Excia Total Hip SystemAesculap, Inc. · 2005 · cites it directly198descendants
- K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006 · 2 generations on90descendants
- K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 2 generations on90descendants
- K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · 2 generations on83descendants
- K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007 · 2 generations on79descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031474 | SC Total Hip System | Orthopedic Alliance, LLC | 2003 | — |
| +1 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| +2 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| +2 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| +2 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| +2 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 11 | 0 |
| 2012 | 15 | 0 |
| 2013 | 11 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 12 | 0 |
| 2018 | 9 | 0 |
| 2019 | 5 | 0 |
| 2020 | 9 | 0 |
| 2021 | 17 | 0 |
| 2022 | 13 | 0 |
| 2023 | 14 | 0 |
| 2024 | 9 | 0 |
| 2025 | 19 | 0 |
| 2026 | 16 | 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 |
|---|---|---|---|
| * | — | SL-Plus Hip Stem (Plus Orthopedics) Named without a submission number | |
| * | — | Zweymuller SL Hip System (AlloPro) Named without a submission number | |
| * | — | Lester Press Fit Hip System (Kirschner) Named without a submission number | |
| * | — | Alloclassic Zweymuller SL Hip Stem (Sulzer Medica) Named without a submission number |
What descends from it? (200)
See all 2002 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?
- Of its descendants, K042344 (Aesculap, Inc., 2005) has gone furthest, with 198 descendants of its own.
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.
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 SC Total Hip System is indicated for use in the treatment of severely disabled hip joints resulting from painful osteo-, rheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries.
The SC Femoral Hip Stem is indicated for use with or without bone cement.
The SC Acetabular Cup is for use with bone cement only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031474: SC Total Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031474
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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