510(k) · Cleared
ClearedPatient Matched Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jul 12, 2006 as substantially equivalent to K963509 (Smith & Nephew Richards, Inc., 1997) and 2 other predicates after a 233-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Jul 12, 2006
- Review
- 233 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K923452 (1994). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923452 | Pmi Hip Femoral | Biomet, Inc. | 1994 | — |
| 0 (this device) | K053246 | Patient Matched Hip Stem | Smith & Nephew, Inc. | 2006 | — |
| +1 | K123598 | Smith & Nephew, Inc. Hip System Instrumentation | Smith & Nephew, Inc. | 2013 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (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 |
|---|---|---|---|
| * | K963509 | Global Taper Tapered Hip System, GT SpectronSummary page 2…he intended use, design, and materials of the Smith & Nephew Patient Matched Hip Stem are substantially equivalent to the Smith & Nephew Synergy Global Taper Hip System (K963509), the Smith & Nephew ANTHOLOGY Hip Stem (K052792), and the Biomet Patient Matched Implants (K923452). DEPAR… | 1997 |
| * | K052792 | Anthology Hip StemSummary page 2…th & Nephew Patient Matched Hip Stem are substantially equivalent to the Smith & Nephew Synergy Global Taper Hip System (K963509), the Smith & Nephew ANTHOLOGY Hip Stem (K052792), and the Biomet Patient Matched Implants (K923452). DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2005 |
| * | K923452 | Pmi Hip FemoralSummary page 2…lly equivalent to the Smith & Nephew Synergy Global Taper Hip System (K963509), the Smith & Nephew ANTHOLOGY Hip Stem (K052792), and the Biomet Patient Matched Implants (K923452). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 1994 |
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 |
|---|---|---|---|
| K123598 | Smith & Nephew, Inc. Hip System Instrumentation | 2013 | 0 |
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?
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 Smith & Nephew Patient Matched Hip Stem is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip…
Read the full statement (293 words)
The Smith & Nephew Patient Matched Hip Stem is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The REFLECTION Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
The Endoprostheses System is indicated for non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis; rheumatoid arthritis; arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysptasia or ankylosing spondylitis; revision procedures where other treatments have failed; and treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.
The Patient Match d Hip Stem is for uncemented, single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053246 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053246: Patient Matched Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053246
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