510(k) · Cleared
ClearedModification to Reflection Cross-Linked Uhmwpe Acetabular Components
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 Dec 5, 2001 as substantially equivalent to K002747 (Smith & Nephew, Inc., 2000) after a 29-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.
- Decided
- Dec 5, 2001
- Review
- 29 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002747 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002747 Reflection Cross-Linked Uhmwpe Acetabular ComponentsSmith & Nephew, Inc. · 2000
- This deviceK013658 Modification to Reflection Cross-Linked Uhmwpe Acetabular ComponentsSmith & Nephew, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK160895 Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation · 2016
- Descendant · 2 generations on · 0 of its ownK242045 Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK243444 Bioceram Azul® HeadKyocera Corporation · 2024
Most influential descendants
Showing 3 of 3 · See all- K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation · 2016 · cites it directly2descendants
- K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc. · 2025 · 2 generations on0descendants
- K243444Bioceram Azul® HeadKyocera Corporation · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002747 | Reflection Cross-Linked Uhmwpe Acetabular Components | Smith & Nephew, Inc. | 2000 | — |
| 0 (this device) | K013658 | Modification to Reflection Cross-Linked Uhmwpe Acetabular Components | Smith & Nephew, Inc. | 2001 | — |
| +1 | K160895 | Initia Total Hip System & BIOCERAM AZUL (R) HEAD | Kyocera Medical Corporation | 2016 | — |
| +2 | K242045 | Initia T3 Acetabular Hemispherical Shell System | Kyocera Medical Technologies, Inc. | 2025 | — |
| +2 | K243444 | Bioceram Azul® Head | Kyocera Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 24.2 · 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? (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 |
|---|---|---|---|
| * | K002747 | Reflection Cross-Linked Uhmwpe Acetabular ComponentsSummary page 1…and design features of the Reflection® Cross-linked UHMWPE Acetabular Components are identical to Smith and Nephew, Inc. predicate counterparts cleared for market under K002747. This Special 510(k) premarket notification is requesting approval for use of Reflection® 10 Mrad Cross-Linked UHMWPE Acetabula… | 2000 |
| * | — | Zirconia Ceramic Femoral Heads Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160895 | Initia Total Hip System & BIOCERAM AZUL (R) HEAD | 2016 | 2 |
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 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 (108 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 and diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; non-union; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013658 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013658: Modification to Reflection Cross-Linked Uhmwpe Acetabular Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013658
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026