510(k) · Cleared
ClearedLinear Porous Coated Hip Stem, Size 5; Revelation Hip Stem, Size 8; Foundation Porous Press Fit Stem, Size 8;
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jun 19, 2012 as substantially equivalent to K991226 (Encore Orthopedics, Inc., 1999) and 3 other predicates after a 76-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Jun 19, 2012
- Review
- 76 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K952191 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK952191 Forged Cemented StemEncore Orthopedics, Inc. · 1995
- 2 generations backK961890 Foundation 9MM Forged Cemented StemEncore Orthopedics, Inc. · 1996 · Recalled
- 1 generation backK991227 8MM Forged Cemented StemEncore Orthopedics, Inc. · 1999
- This deviceK121024 Linear Porous Coated Hip Stem, Size 5; Revelation Hip Stem, Size 8…Encore Medical L.P. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952191 | Forged Cemented Stem | Encore Orthopedics, Inc. | 1995 | — |
| −2 | K961890 | Foundation 9MM Forged Cemented Stem | Encore Orthopedics, Inc. | 1996 | 1 |
| −1 | K991227 | 8MM Forged Cemented Stem | Encore Orthopedics, Inc. | 1999 | — |
| 0 (this device) | K121024 | Linear Porous Coated Hip Stem, Size 5; Revelation Hip Stem, Size 8; Foundation… | Encore Medical L.P. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K990135 | FDA’s K990135 is Trilogy Acetabular System Longevity Crosslinked Polyethylene Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1999 |
| Kept off the family tree | K990070 | Revelation Hip Stem, Size 8 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K991226 | Foundation Porous Hip StemSummary page 1…strained porous coated uncemented 8 .prosthesis per 21 CFR 888.3358 Foundation Porous Press K99 1226 -June 1, 1999, Class Hip joint metal/ceramic/polymer semiu- Fit Stem, Size 8 11… | 1999 |
| * | K952191 | Forged Cemented StemSummary page 1…mented or nonporous uncemented prosthesis per 21 CFR 888.3353 Foundation Cemented Hip K(952191 -July 17, 1995, Class JDI, Hip joint metal/polymer semi-constrained Stem, Size 10. 5 - 18 11… | 1995 |
| * | K991227 | 8MM Forged Cemented StemSummary page 1…olymer semi-constrained Stem, Size 10. 5 - 18 11 JDG cemented prosthesis per 21 CFR 888.3350 Foundation Cemented K991227 - June 1, 1999, Class JD1 Hip joint metal/polymer semi-constrained Stem, Size 8 11… | 1999 |
| * | K961890 | Foundation 9MM Forged Cemented StemSummary page 1…ymer semi-constrained Stem, Size 8 11 cemented prosthesis per 21 CER 888.3350 Foundation Cemented K(961890 -June 14, 1996, Class iDI Hip joint metal/polymer semi-constrained Stem, Size 9 11… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K991226.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
Joint replacement is indicated for patients suffering from disability due to: * noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; * rheumatoid arthritis; * correction of functional deformity; * femoral fracture; This device may also be indicated in the salvage of previously failed surgical attempts. This stem is intended to be used in a cementless mode. Joint replacement is indicated…
Read the full statement (372 words)
Joint replacement is indicated for patients suffering from disability due to:
* noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
* rheumatoid arthritis;
* correction of functional deformity;
* femoral fracture;
This device may also be indicated in the salvage of previously failed surgical attempts. This stem is intended to be used in a cementless mode.
Joint replacement is indicated for patients suffering from disability due to:
o noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
* rheumatoid arthritis;
o correction of functional deformity;
* femoral fracture;
This device may also be indicated in the salvage of previously failed surgical attempts. This stem is intended to be used in a cementless mode.
Joint replacement is indicated for patients suffering from disability due to:
" noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
" rheumatoid arthritis;
* correction of functional deformity;
" femoral fracture;
This device may also be indicated in the salvage of previously failed surgical attempts. This stem is intended to be used in a cementless mode.
Joint replacement is indicated for patients suffering from disability due to:
" noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
" rheumatoid arthritis;
* correction of functional deformity;
" femoral fracture;
This device may also be indicated in the salvage of previously failed surgical attempts. This stem is intended to be used in a cemented mode.
Joint replacement is indicated for patients suffering from disability due to:
" noninflanmmatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
" rheumatoid arthritis;
* correction of fuinctional deformity;
* femoral fracture;
This device may also be indicated in the salvage of previously failed surgical attempts. This stem is intended to be used in a cemented mode.
Joint replacement is indicated for patients suffering from disability due to:
" noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
" rheumatoid arthritis;
* correction of fictional deformity;
" femoral fracture;
This device may also be indicated in the salvage of previously failed surgical attempts. This stem is intended to be used in a cemented mode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121024: Linear Porous Coated Hip Stem, Size 5; Revelation Hip Stem, Size 8; Foundation Porous Press Fit Stem, Size 8;.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121024
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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