510(k) · Cleared
Recalled · 2008Hipstar Femoral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Orthopaedics · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on May 10, 2006 as substantially equivalent to K030373 (Centerpulse Orthopedics, Inc., 2003) after a 363-day review. Its family tree reaches back 3 generations to 1987. 1 later device descends from it. It has been recalled once.
- Decided
- May 10, 2006
- Review
- 363 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K871453 (1987). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK871453 Zweymueller-SL Hip Prosthesis StemAllo Pro Corp. · 1987
- 2 generations backK962101 Zweymueller SL Femoral Hip StemIntermedics Orthopedics · 1996
- 1 generation backK030373 Alloclassic Zweymueller SL/SLL Femoral StemCenterpulse Orthopedics, Inc. · 2003 · Recalled
- This deviceK051223 Hipstar Femoral StemStryker Orthopaedics · 2006
- Descendant · cites it directly · 0 of its ownK063822 Modification to Hipstar Femoral StemStryker Orthopaedics · 2007 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K063822Modification to Hipstar Femoral StemStryker Orthopaedics · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871453 | Zweymueller-SL Hip Prosthesis Stem | Allo Pro Corp. | 1987 | — |
| −2 | K962101 | Zweymueller SL Femoral Hip Stem | Intermedics Orthopedics | 1996 | — |
| −1 | K030373 | Alloclassic Zweymueller SL/SLL Femoral Stem | Centerpulse Orthopedics, Inc. | 2003 | 1 |
| 0 (this device) | K051223 | Hipstar Femoral Stem | Stryker Orthopaedics | 2006 | — |
| +1 | K063822 | Modification to Hipstar Femoral Stem | Stryker Orthopaedics | 2007 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 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 |
|---|---|---|---|
| * | K030373 | Alloclassic Zweymueller SL/SLL Femoral StemSummary page 2…t hip stem is based on its similarities in intended use, design and sterilization to Zimmer's Alloclassi~mf ZweyrnuellerTml SIJSLL. femoral hip stem (K030373, cleared March 06,2003). CT/se BSVd 8SGSISBTOg… | 2003 |
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 |
|---|---|---|---|
| K063822 | Modification to Hipstar Femoral Stem | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 20, 2008 | Not classified | Z-0227-2009 | Labeling mix-ups | The warning label "do not use with heads more than +10, offset" does not appear on 135 degree stem boxes. This warning is contained in the instructions for use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K063822 (Stryker Orthopaedics, 2007) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K030373.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
The Hipstar® Hip Stem is intended for use in total and hemi hip arthroplasty for the following indications: * noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; * rheumatoid arthritis (excepting the Osteolock TM 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…
Read the full statement (140 words)
The Hipstar® Hip Stem is intended for use in total and hemi hip arthroplasty for the
following indications:
* noninflammatory degenerative joint disease including osteoarthritis and avascular
necrosis;
* rheumatoid arthritis (excepting the Osteolock TM 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.
When mated with a constrained acetabular liner the H-ipstar® Hip Stem is indicated for use
in primary and revision total hip arthroplasty for patients at high risk of hip dislocation due
to a history of prior dislocations, bone loss, joint or soft tissue laxity, neuromuscular disease
or intraoperative instability.
The Hipstar® Hip Stem is intended for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051223: Hipstar Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051223
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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