510(k) · Cleared
ClearedDual Offset Perfecta Imc Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Oct 9, 1997 after an 86-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Oct 9, 1997
- Review
- 86 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK972641 Dual Offset Perfecta Imc Hip StemWrightmedicaltechnologyinc · 1997
- Descendant · cites it directly · 4 of its ownK061344 Excia Total Hip System Lateral OffsetAesculap, Inc. · 2006
- Descendant · 2 generations on · 3 of its ownK092143 Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc. · 2009
- Descendant · 3 generations on · 2 of its ownK140915 Excia Total Hip SystemAesculap Implant Systems, LLC · 2014
- Descendant · 4 generations on · 1 of its ownK150062 Excia Total Hip SystemAesculap Implant Systems, LLC · 2015
- Descendant · 2 generations on · 0 of its ownK172235 CoreHip® SystemAesculap Implants Systems, LLC · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K061344Excia Total Hip System Lateral OffsetAesculap, Inc. · 2006 · cites it directly4descendants
- K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc. · 2009 · 2 generations on3descendants
- K140915Excia Total Hip SystemAesculap Implant Systems, LLC · 2014 · 3 generations on2descendants
- K150062Excia Total Hip SystemAesculap Implant Systems, LLC · 2015 · 4 generations on1descendant
- K172235CoreHip® SystemAesculap Implants Systems, LLC · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972641 | Dual Offset Perfecta Imc Hip Stem | Wrightmedicaltechnologyinc | 1997 | — |
| +1 | K061344 | Excia Total Hip System Lateral Offset | Aesculap, Inc. | 2006 | — |
| +2 | K092143 | Excia Total Hip System M an ML Femoral Stem | Aesculap Implant Systems, Inc. | 2009 | — |
| +3 | K140915 | Excia Total Hip System | Aesculap Implant Systems, LLC | 2014 | — |
| +4 | K150062 | Excia Total Hip System | Aesculap Implant Systems, LLC | 2015 | — |
| +2 | K172235 | CoreHip® System | Aesculap Implants Systems, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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 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 |
|---|---|---|---|
| * | — | PERFECTA® IMC Hip Stem manufactured by Wright Medical Technology, Inc. Named without a submission number |
What descends from it? (6)
2 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, K061344 (Aesculap, Inc., 2006) has gone furthest, with 4 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?
This device is indicated in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. Inflammatory degenerative joint disease such as rheumatoid arthritis; 3. Correction of function deformity; 4, Revision procedures…
Read the full statement (99 words)
This device is indicated in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. Inflammatory degenerative joint disease such as rheumatoid arthritis;
3. Correction of function deformity;
4, Revision procedures where other treatments or devices have failed; and
5. Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
This device is intended for use with bone cement.
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/K972641 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972641: Dual Offset Perfecta Imc Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972641
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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