510(k) · Cleared
ClearedEncore Linear Hip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Orthopedics, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Jan 12, 1998 after a 168-day review. The FDA summary names no predicate by number. 7 later devices descend from it.
- Decided
- Jan 12, 1998
- Review
- 168 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK972791 Encore Linear HipEncore Orthopedics, Inc. · 1998
- Descendant · cites it directly · 5 of its ownK141327 Minima S SystemLima Corporate S.P.A. · 2014
- Descendant · cites it directly · 4 of its ownK140975 Mastersl Femoral StemLima Corporate S.P.A. · 2014
- Descendant · 2 generations on · 3 of its ownK143509 MasterSL femoral stemLima Corporate S.P.A. · 2015
- Descendant · 2 generations on · 2 of its ownK150855 H-MAX S Femoral Hip SystemLima Corporate S.P.A. · 2015
- Descendant · 3 generations on · 1 of its ownK160011 H-Max S stemLima Corporate S.P.A. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K141327Minima S SystemLima Corporate S.P.A. · 2014 · cites it directly5descendants
- K140975Mastersl Femoral StemLima Corporate S.P.A. · 2014 · cites it directly4descendants
- K143509MasterSL femoral stemLima Corporate S.P.A. · 2015 · 2 generations on3descendants
- K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A. · 2015 · 2 generations on2descendants
- K160011H-Max S stemLima Corporate S.P.A. · 2016 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972791 | Encore Linear Hip | Encore Orthopedics, Inc. | 1998 | — |
| +1 | K141327 | Minima S System | Lima Corporate S.P.A. | 2014 | — |
| +1 | K140975 | Mastersl Femoral Stem | Lima Corporate S.P.A. | 2014 | — |
| +2 | K143509 | MasterSL femoral stem | Lima Corporate S.P.A. | 2015 | — |
| +2 | K150855 | H-MAX S Femoral Hip System | Lima Corporate S.P.A. | 2015 | — |
| +3 | K160011 | H-Max S stem | Lima Corporate S.P.A. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 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?
The FDA summary names no predicate by number.
What descends from it? (7)
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, K141327 (Lima Corporate S.P.A., 2014) has gone furthest, with 5 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 indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. This stem is intended to be used with 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/K972791 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972791: Encore Linear Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972791
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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