510(k) · Cleared
ClearedTaperfill Femoral Hip Stem 425-31-005_017 425-41-005_019
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 21, 2013 as substantially equivalent to K974294 (Encore Orthopedics, Inc., 1998) and 2 other predicates after a 157-day review. Its family tree reaches back 2 generations to 1999. 4 later devices descend from it.
- Decided
- Jun 21, 2013
- Review
- 157 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K991325 (1999). 4 ancestors in all, the oldest K974294 (1998). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK991325 Modification of Encore Linear Porous Coated HipEncore Orthopedics, Inc. · 1999
- 1 generation backK120241 Linear Hip Stem, Size 5Encore Medical L.P. · 2012 · Recalled
- This deviceK130099 Taperfill Femoral Hip Stem 425-31-005_017 425-41-005_019Encore Medical L.P. · 2013
- Descendant · cites it directly · 1 of its ownK223103 BethaLoc® stem cementless HAImplantcast GmbH · 2023
- Descendant · cites it directly · 1 of its ownK161610 EXPRT Revision Hip SystemEncore Medical L.P. · 2016
- Descendant · 2 generations on · 0 of its ownK260037 implantcast Packaging System UpdateImplantcast GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK163497 EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip…Encore Medical L.P. · 2017 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K223103BethaLoc® stem cementless HAImplantcast GmbH · 2023 · cites it directly1descendant
- K161610EXPRT Revision Hip SystemEncore Medical L.P. · 2016 · cites it directly1descendant
- K260037implantcast Packaging System UpdateImplantcast GmbH · 2026 · 2 generations on0descendants
- K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal…Encore Medical L.P. · 2017 · 2 generations on0descendants
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) | K130099 | Taperfill Femoral Hip Stem 425-31-005_017 425-41-005_019 | Encore Medical L.P. | 2013 | — |
| +1 | K223103 | BethaLoc® stem cementless HA | Implantcast GmbH | 2023 | — |
| +1 | K161610 | EXPRT Revision Hip System | Encore Medical L.P. | 2016 | — |
| +2 | K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026 | — |
| +2 | 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 |
|---|---|---|
| 1998 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K974294 | Encore Linear Porous Coated HipSummary page 1…ed Hip Stem. The TaperFill Femoral Hip stem is designed with a reduced neck, shorter length, and increased proximal width as compared to the predicate Linear™ Hip Stem (K974294).The TaperFill™ stem has an equivalent or larger cross section area in all locations. The TaperFill™ Femoral Hip Stem is fabrica… | 1998 |
| * | K081679 | Revelation Hip Stem, Models, 427-01, 427-02; Linear Hip Stem, Models 425-00, 425-05Summary page 2…ered. This stem is to be press-fit. This stem is intended for cementless use. Predicate Device: e Linear™ Porous Coated Hip Stem — K974294 e P2 Coating on Linear Stem— K081679 o P2 Coating on Linear Hip Stem Size 8 — K120241 Comparable Features to Predicate Device(s): Features comparable to predicate de… | 2008 |
| * | K120241 | Linear Hip Stem, Size 5Summary page 2…intended for cementless use. Predicate Device: e Linear™ Porous Coated Hip Stem — K974294 e P2 Coating on Linear Stem— K081679 o P2 Coating on Linear Hip Stem Size 8 — K120241 Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same indications, materials, st… | 2012 |
What descends from it? (4)
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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 12.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K223103 (Implantcast GmbH, 2023) has gone furthest, with 1 descendant of its own.
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. 2013, 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. The constrained acetabular component is indicated for primary or revision patients at high…
Read the full statement (111 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.
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.
This stem is to be press-fit. This stem is intended for cementless use.
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/K130099 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130099: Taperfill Femoral Hip Stem 425-31-005_017 425-41-005_019.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130099
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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