510(k) · Cleared
ClearedReflection Modified Acetabular Shells
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Aug 28, 2002 after a 26-day review. The FDA summary names no predicate by number. 30 later devices descend from it.
- Decided
- Aug 28, 2002
- Review
- 26 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 4 citing it directly.
- This deviceK022556 Reflection Modified Acetabular ShellsSmith & Nephew, Inc. · 2002
- Descendant · cites it directly · 24 of its ownK090982 Smith & Nephew Hip Systems with HASmith & Nephew, Inc. · 2010
- Descendant · 2 generations on · 22 of its ownK101072 Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium…Howmedica Osteonics Corp. · 2011
- Descendant · 3 generations on · 21 of its ownK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
- Descendant · 4 generations on · 20 of its ownK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
- Descendant · 5 generations on · 19 of its ownK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K090982Smith & Nephew Hip Systems with HASmith & Nephew, Inc. · 2010 · cites it directly24descendants
- K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp. · 2011 · 2 generations on22descendants
- K122158PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012 · 3 generations on21descendants
- K131237Pipeline Total Hip SystemPipeline Orthopedics · 2013 · 4 generations on20descendants
- K161184iNSitu Total Hip SystemTheken Companies, LLC · 2016 · 5 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022556 | Reflection Modified Acetabular Shells | Smith & Nephew, Inc. | 2002 | — |
| +1 | K090982 | Smith & Nephew Hip Systems with HA | Smith & Nephew, Inc. | 2010 | — |
| +2 | K101072 | Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-Apatite | Howmedica Osteonics Corp. | 2011 | — |
| +3 | K122158 | PBP Total Hip System | Pipeline Biomedical Products, LLC | 2012 | — |
| +4 | K131237 | Pipeline Total Hip System | Pipeline Orthopedics | 2013 | — |
| +5 | K161184 | iNSitu Total Hip System | Theken Companies, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2026 | 5 | 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?
The FDA summary names no predicate by number.
What descends from it? (30)
See all 304 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K090982 (Smith & Nephew, Inc., 2010) has gone furthest, with 24 descendants of its own.
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.
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?
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the…
Read the full statement (107 words)
Total hip components are indicated for individuals undergoing primary and revision
surgery where other treatments or devices have failed in rehabilitating hips damaged as a
result of trauma, inflammatory joint disease such as rheumatoid arthritis, or
noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses
such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis;
fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an
extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures
of the proximal femur with heads involvement that are unmanageable using other
techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip;
and correction of deformity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022556 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022556: Reflection Modified Acetabular Shells.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022556
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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