510(k) · Cleared
ClearedStability Hip Stem with Porocoat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jul 6, 1994 as substantially equivalent to K915787 (Depuy, Inc., 1993) after a 296-day review. Its family tree reaches back 1 generation to 1993. 1 of the 196 devices in its family, counting itself, has a Class I recall. 194 later devices descend from it.
- Decided
- Jul 6, 1994
- Review
- 296 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915787 (1993). 194 later devices descend from it, 4 citing it directly. 1 of the 196 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK915787 Stability Hip Stem with PorocoatDepuy, Inc. · 1993
- This deviceK934457 Stability Hip Stem with PorocoatDepuy, Inc. · 1994
- Descendant · cites it directly · 188 of its ownK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
- Descendant · 2 generations on · 168 of its ownK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 71 of its ownK082525 Corin Metafix Femoral StemCorin USA · 2010 · Recalled
- Descendant · 4 generations on · 61 of its ownK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
- Descendant · 3 generations on · 49 of its ownK070554 Depuy Corail Amt Dysplasia Hip ProsthesisDePuy Orthopaedics, Inc. · 2007
Showing 5 of 194 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K071417 Depuy LPS Diaphyseal and Metaphyseal Sleevescites it directly · 2007
Most influential descendants
Showing 5 of 194 · See all- K001991Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000 · cites it directly188descendants
- K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · 2 generations on168descendants
- K082525Corin Metafix Femoral StemCorin USA · 2010 · 3 generations on71descendants
- K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012 · 4 generations on61descendants
- K070554Depuy Corail Amt Dysplasia Hip ProsthesisDePuy Orthopaedics, Inc. · 2007 · 3 generations on49descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915787 | Stability Hip Stem with Porocoat | Depuy, Inc. | 1993 | — |
| 0 (this device) | K934457 | Stability Hip Stem with Porocoat | Depuy, Inc. | 1994 | — |
| +1 | K001991 | Titan Porocoat Hip Prosthesis | DePuy Orthopaedics, Inc. | 2000 | — |
| +2 | K042992 | Corail Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2005 | 1 |
| +3 | K082525 | Corin Metafix Femoral Stem | Corin USA | 2010 | 2 |
| +4 | K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | Corin USA | 2012 | — |
| +3 | K070554 | Depuy Corail Amt Dysplasia Hip Prosthesis | DePuy Orthopaedics, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 1 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 10 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 9 | 0 |
| 2017 | 12 | 0 |
| 2018 | 12 | 0 |
| 2019 | 14 | 0 |
| 2020 | 16 | 0 |
| 2021 | 9 | 0 |
| 2022 | 15 | 0 |
| 2023 | 19 | 0 |
| 2024 | 15 | 0 |
| 2025 | 18 | 0 |
| 2026 | 14 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K915787 | Stability Hip Stem with PorocoatSummary page 4…cation is EQUIVALENCE: substantially equivalent (i.e., identical) to the Stability Hip Stem with Porocoat for cemented application (K915787) in design and material. Both include a porous coating on the proximal body. The… | 1993 |
| * | — | AML Porocoat Femoral Stem Named without a submission number |
What descends from it? (194)
See all 1944 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K071417Depuy LPS Diaphyseal and Metaphyseal SleevesDePuy Orthopaedics, Inc. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
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 Stability Hip Prosthesis is indicated for uncemented use as the femoral component in total hip arthroplasty for replacing the hip joint of patients whose hip joint has been damaged by degenerative joint disease, fracture, or the failure of a previous arthroplasty. The articular surface of the prosthesis is provided by the attachment of a modular femoral head of cobalt-chromium-molybdenum alloy (Orthochrome) or aluminum oxide ceramic (Biolox) for use…
Read the full statement (114 words)
The Stability Hip Prosthesis is indicated for uncemented use as the femoral component in total hip arthroplasty for replacing the hip joint of patients whose hip joint has been damaged by degenerative joint disease, fracture, or the failure of a previous arthroplasty. The articular surface of the prosthesis is provided by the attachment of a modular femoral head of cobalt-chromium-molybdenum alloy (Orthochrome) or aluminum oxide ceramic (Biolox) for use in total hip replacement with a porous coated metal-backed acetabular component with a bearing surface made of ultra high molecular weight polyethylene. Fixation of the Stability Hip to the skeleton is intended to be by uncemented, biological fixation by tissue ingrowth into the porous coating.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K934457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934457: Stability Hip Stem with Porocoat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934457
Report an extraction error
Are you the manufacturer?
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