510(k) · Cleared
Recalled · 2007Modification to Hipstar Femoral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Orthopaedics · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jan 25, 2007 as substantially equivalent to K051223 (Stryker Orthopaedics, 2006) after a 30-day review. Its family tree reaches back 4 generations to 1987. It has been recalled once.
- Decided
- Jan 25, 2007
- Review
- 30 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K871453 (1987). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK871453 Zweymueller-SL Hip Prosthesis StemAllo Pro Corp. · 1987
- 3 generations backK962101 Zweymueller SL Femoral Hip StemIntermedics Orthopedics · 1996
- 2 generations backK030373 Alloclassic Zweymueller SL/SLL Femoral StemCenterpulse Orthopedics, Inc. · 2003 · Recalled
- 1 generation backK051223 Hipstar Femoral StemStryker Orthopaedics · 2006 · Recalled
- This deviceK063822 Modification to Hipstar Femoral StemStryker Orthopaedics · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871453 | Zweymueller-SL Hip Prosthesis Stem | Allo Pro Corp. | 1987 | — |
| −3 | K962101 | Zweymueller SL Femoral Hip Stem | Intermedics Orthopedics | 1996 | — |
| −2 | K030373 | Alloclassic Zweymueller SL/SLL Femoral Stem | Centerpulse Orthopedics, Inc. | 2003 | 1 |
| −1 | K051223 | Hipstar Femoral Stem | Stryker Orthopaedics | 2006 | 1 |
| 0 (this device) | K063822 | Modification to Hipstar Femoral Stem | Stryker Orthopaedics | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 |
|---|---|---|---|
| * | K051223 | Hipstar Femoral StemSummary page 2…ng other techniques * intended for cementless fixation. Substantial Equivalence: The subject Hipstar femoral stem is a modification to the Hipstar stem cleared in K051223. The determination of the substantial equivalence of the Hipstar hip stem is based on its similarities in intended use, design an… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 28, 2007 | Not classified | Z-0463-2008 | Packaging process control | Mis-labeled: The warning label "Do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes. |
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 6.5 years on median.
- 2 of the 5 ancestors have a recall of any class.
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. 2007, 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?
noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
rheumatoid arthritis (excepting the Osteolock™ HA Acetabular Cup and Peri-Apatite coated prostheses);
correction of functional deformity;
revision procedures where other treatments or devices have failed; and,
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063822 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063822: Modification to Hipstar Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063822
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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