510(k) · Cleared
ClearedRevelation Porous Coated Hip 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 Nov 2, 2012 as substantially equivalent to K994070 (Encore Orthopedics, Inc., 2000) and 1 other predicate after a 65-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Nov 2, 2012
- Review
- 65 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K994070 (2000). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK994070 Revelation Porous Hip StemEncore Orthopedics, Inc. · 2000
- This deviceK122636 Revelation Porous Coated Hip Stem, Size 8Encore Medical L.P. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K994070 | Revelation Porous Hip Stem | Encore Orthopedics, Inc. | 2000 | — |
| 0 (this device) | K122636 | Revelation Porous Coated Hip Stem, Size 8 | Encore Medical L.P. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (2)
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 |
|---|---|---|---|
| * | K994070 | Revelation Porous Hip StemSummary page 2…Page 2 === Predicate Device: JA 2aC3K (p, 5-0 2) DJO Surgical Revelation Hip Stem, Size 82 - K994070 DJO Surgical Revelation Hip Stem with p Coating - KO081679 Comparable Features to Predicate Device(s): Fe… | 2000 |
| * | K081679 | Revelation Hip Stem, Models, 427-01, 427-02; Linear Hip Stem, Models 425-00, 425-05Summary page 2…5-0 2) DJO Surgical Revelation Hip Stem, Size 82 - K994070 DJO Surgical Revelation Hip Stem with p Coating - KO081679 Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same design features, materials… | 2008 |
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?
- None of the 2 ancestors has a recall.
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: non inflammatory 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 The constrained acetabular component is indicated for primary or revision patients at high risk of…
Read the full statement (102 words)
Joint replacement is indicated for patients suffering from disability due to:
non inflammatory 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
The constrained acetabular component is indicated for primary or revision patients at high risk of
hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular
disease, or intra-operative instability and for who all other options to constrained acetabular
components have been considered.
The device is intended for cementless applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122636: Revelation Porous Coated Hip 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/K122636
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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