510(k) · Cleared
ClearedEXPRT Revision Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Cleared on Nov 9, 2016 as substantially equivalent to K092331 (Encore Medical L.P., 2010) and 2 other predicates after a 152-day review. Its family tree reaches back 7 generations to 1994. 1 later device descends from it.
- Decided
- Nov 9, 2016
- Review
- 152 days
- Class
- Class II
- Product code
- KWZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K921308 (1994). 44 ancestors in all, the oldest K850055 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 6 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 5 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 4 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 3 generations backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
- 2 generations backK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · Recalled
- 1 generation backK092331 Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P. · 2010 · Recalled
- This deviceK161610 EXPRT Revision Hip SystemEncore Medical L.P. · 2016
- Descendant · cites it directly · 0 of its ownK163497 EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip…Encore Medical L.P. · 2017 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal…Encore Medical L.P. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −6 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −5 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −4 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −3 | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | 3 |
| −2 | K090757 | Biomet Modular Femoral Revision System | Biomet, Inc. | 2009 | 18 |
| −1 | K092331 | Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200… | Encore Medical L.P. | 2010 | 1 |
| 0 (this device) | K161610 | EXPRT Revision Hip System | Encore Medical L.P. | 2016 | — |
| +1 | K163497 | EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard… | Encore Medical L.P. | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 KWZ? 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 KWZ device
- #1 K241461 Mpact Constrained Linerscore 15.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K092331 | Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Summary page 4…. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants. Predicate Devices: DJO Modular Revision Hip System – K092331 DJO TaperFill Hip Stem – K130099 Stryker Restoration Modular Revision Hip Sys… | 2010 |
| * | K130099 | Taperfill Femoral Hip Stem 425-31-005_017 425-41-005_019Summary page 4…n both uncemented and cemented femoral implants. Predicate Devices: DJO Modular Revision Hip System – K092331 DJO TaperFill Hip Stem – K130099 Stryker Restoration Modular Revision Hip System – K050138 Comparable Features to Predicate Device(s):… | 2013 |
| * | K050138 | Modification to: Restoration Modular SystemSummary page 4…ular Revision Hip System – K092331 DJO TaperFill Hip Stem – K130099 Stryker Restoration Modular Revision Hip System – K050138 Comparable Features to Predicate Device(s): This device is comparable to the predicate devices in indications, material, desig… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163497 | EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal… | 2017 | 0 |
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 22 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 20 of the 44 ancestors have a recall of any class.
- Of its descendants, K163497 (Encore Medical L.P., 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K092331.
How does its category compare?
All KWZ devicesKWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · KWZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWZ
104in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWZ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWZ
193in 2025
MAUDE reports naming product code KWZ, 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 | 7 | 104 | 0 | 41 |
| 2008 | 1 | — | 0 | 44 |
| 2009 | 1 | — | 0 | 81 |
| 2010 | 1 | — | 8 | 98 |
| 2011 | 1 | — | 0 | 127 |
| 2012 | 1 | — | 1 | 168 |
| 2013 | 0 | — | 0 | 274 |
| 2014 | 0 | — | 0 | 278 |
| 2015 | 0 | — | 0 | 636 |
| 2016 | 1 | — | 0 | 1,180 |
| 2017 | 2 | — | 0 | 477 |
| 2018 | 0 | — | 0 | 283 |
| 2019 | 0 | — | 0 | 532 |
| 2020 | 0 | — | 0 | 288 |
| 2021 | 0 | — | 0 | 216 |
| 2022 | 0 | — | 0 | 158 |
| 2023 | 0 | — | 1 | 164 |
| 2024 | 1 | — | 0 | 145 |
| 2025 | 1 | — | 0 | 193 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Exprt™ Revision Hip System is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.
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/K161610 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161610: EXPRT Revision Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161610
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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