510(k) · Cleared
ClearedAlpine Hip Stem; Alpine HA Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Development · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jul 30, 2014 as substantially equivalent to K062775 (Ortho Development Corp., 2007) and 2 other predicates after a 103-day review. Its family tree reaches back 6 generations to 1994. 4 later devices descend from it.
- Decided
- Jul 30, 2014
- Review
- 103 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K931641 (1994). 54 ancestors in all, the oldest K830313 (1983). 4 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 5 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 4 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 3 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 2 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 1 generation backK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- This deviceK141001 Alpine Hip Stem; Alpine HA Hip StemOrtho Development · 2014
- Descendant · cites it directly · 3 of its ownK173880 Corin TriFit CF Hip StemCorin U.S.A. Limited · 2018
- Descendant · 2 generations on · 2 of its ownK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK241472 Icona Hip StemCorin U.S.A. Limited · 2024
- Descendant · 3 generations on · 0 of its ownK261576 Icona Hip StemCorin, Ltd. · 2026
Most influential descendants
Showing 4 of 4 · See all- K173880Corin TriFit CF Hip StemCorin U.S.A. Limited · 2018 · cites it directly3descendants
- K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd. · 2021 · 2 generations on2descendants
- K241472Icona Hip StemCorin U.S.A. Limited · 2024 · 2 generations on1descendant
- K261576Icona Hip StemCorin, Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −5 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −4 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −3 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −2 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −1 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| 0 (this device) | K141001 | Alpine Hip Stem; Alpine HA Hip Stem | Ortho Development | 2014 | — |
| +1 | K173880 | Corin TriFit CF Hip Stem | Corin U.S.A. Limited | 2018 | — |
| +2 | K201657 | Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular… | Corin, Ltd. | 2021 | — |
| +2 | K241472 | Icona Hip Stem | Corin U.S.A. Limited | 2024 | — |
| +3 | K261576 | Icona Hip Stem | Corin, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 11 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 6 | 0 |
| 1998 | 1 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 24.3 · 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? (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 |
|---|---|---|---|
| * | K062775 | European Style Taper,Press-Fit Hip StemSummary page 1…Class 11device Device Product Code: LPH, LZO, KWY, KWL, MB!. Predicate Devices: OvationT " Hip Stem (K(062775) Ortho Development Global Taper Tapered Hip System (K(963509) Smith & Nephew… | 2007 |
| * | K963509 | Global Taper Tapered Hip System, GT SpectronSummary page 1…KWL, MB!. Predicate Devices: OvationT " Hip Stem (K(062775) Ortho Development Global Taper Tapered Hip System (K(963509) Smith & Nephew Novation 12/14 Press-Fit Femoral Stem (K042842) Exoctech Device Description… | 1997 |
| * | K042842 | Novation 12/14 Press-Fit Femoral StemSummary page 1…Global Taper Tapered Hip System (K(963509) Smith & Nephew Novation 12/14 Press-Fit Femoral Stem (K042842) Exoctech Device Description The Alpine H-ip Stem is a single-piece, conical tapered femoral hip prostheses, designed for single… | 2004 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173880 | Corin TriFit CF Hip Stem | 2018 | 3 |
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 20 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 8 of the 54 ancestors have a recall of any class.
- Of its descendants, K173880 (Corin U.S.A. Limited, 2018) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K062775.
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. 2014, 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?
This device is intended for use in total hip arthroplasty or hemi-arthroplasty. The device is intended for uncemented, press-fit use only in cases of:
1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis
2. Previously failed hip surgery
3. Proximal femoral neck fractures or dislocation
4. Idiopathic avascular necrosis of femoral head
5. Non-union of Proximal femoral neck fractures
6. Treatment of fractures that are unmanageable using other forms of therapy
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141001 · printed Nov 4, 2026
Cite this page
510(k) Report. “K141001: Alpine Hip Stem; Alpine HA Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K141001
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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