510(k) · Cleared
ClearedEMPOWR™ blade stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical, LLC · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Feb 13, 2023 as substantially equivalent to K120241 (Encore Medical L.P., 2012) after a 59-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Feb 13, 2023
- Review
- 59 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K991325 (1999). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991325 | Modification of Encore Linear Porous Coated Hip | Encore Orthopedics, Inc. | 1999 | — |
| −1 | K120241 | Linear Hip Stem, Size 5 | Encore Medical L.P. | 2012 | 1 |
| 0 (this device) | K223779 | EMPOWR™ blade stem | Encore Medical, LLC | 2023 | — |
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 24.3 · 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? (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 |
|---|---|---|---|
| * | K120241 | Linear Hip Stem, Size 5Summary page 4…21 CFR 888.3358 Regulatory Class: II Primary Product Code: LPH Secondary Product Code: LZO, KWY, KWZ III. PREDICATE DEVICE Primary Predicate: Enovis™ Linear® Hip Stem, K120241 Reference Predicate: Zimmer Biomet™ TaperLoc® Complete Stem, K120030 IV. DEVICE DESCRIPTION The EMPOWR™ blade stem represents t… | 2012 |
| † | K120030 | Taperloc Complete Size 4MM and XR 123 | 2012 |
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 24 years and passes through 3 companies; a new generation was cleared every 12.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K120241.
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. 2023, 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?
The hip joint metal uncemented prosthesis is intended to replace a hip joint. The device is intended 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 intraoperative instability and for whom all other options to constrained acetabular components have been considered. Joint replacement is indicated for patients suffering from disability due to: •…
Read the full statement (119 words)
The hip joint metal uncemented prosthesis is intended to replace a hip joint. The device is intended 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 intraoperative instability and for whom all other options to constrained acetabular components have been considered.
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; and
• revision procedures where other treatments or devices have failed.
This stem is to be press-fit. This stem is intended for cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223779 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223779: EMPOWR™ blade stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223779
Report an extraction error
Are you the manufacturer?
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