510(k) · Cleared
ClearedCocr and Oxinium Femoral Heads and R3 Xlpe Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Cleared on Jan 26, 2010 as substantially equivalent to K022902 (Smith & Nephew, Inc., 2002) and 9 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1996. 16 later devices descend from it.
- Decided
- Jan 26, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- MBL
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 4 generations to K955033 (1996). 44 ancestors in all, the oldest K861766 (1986). 16 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 3 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 2 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- 1 generation backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
- This deviceK093363 Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010
- Descendant · cites it directly · 7 of its ownK113848 R3 Xlpe LinersSmith & Nephew, Inc. · 2012 · Recalled
- Descendant · cites it directly · 6 of its ownK161233 OXINIUM DH Fermoral HeadsSmith & Nephew, Inc. · 2016
- Descendant · cites it directly · 6 of its ownK102370 R3 Xlpe Anteverted LinersSmith & Nephew, Inc. · 2011
- Descendant · 2 generations on · 5 of its ownK191002 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2019
- Descendant · cites it directly · 4 of its ownK182535 R3 Anteverted LinersSmith & Nephew, Inc. · 2018
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K113848R3 Xlpe LinersSmith & Nephew, Inc. · 2012 · cites it directly7descendants
- K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc. · 2016 · cites it directly6descendants
- K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc. · 2011 · cites it directly6descendants
- K191002OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2019 · 2 generations on5descendants
- K182535R3 Anteverted LinersSmith & Nephew, Inc. · 2018 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −3 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −2 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| −1 | K022902 | Smith & Nephew Hip System | Smith & Nephew, Inc. | 2002 | — |
| 0 (this device) | K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe Liners | Smith & Nephew, Inc. | 2010 | — |
| +1 | K113848 | R3 Xlpe Liners | Smith & Nephew, Inc. | 2012 | 2 |
| +1 | K161233 | OXINIUM DH Fermoral Heads | Smith & Nephew, Inc. | 2016 | — |
| +1 | K102370 | R3 Xlpe Anteverted Liners | Smith & Nephew, Inc. | 2011 | — |
| +2 | K191002 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2019 | — |
| +1 | K182535 | R3 Anteverted Liners | Smith & Nephew, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 MBL? 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 MBL device
- #1 K201157 Prime BIOFOAM® Multi-Hole Shellsscore 3.7 · 7 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (10)
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 |
|---|---|---|---|
| * | K022902 | Smith & Nephew Hip SystemSummary page 1…M! ~ ~ ~ Sumssioin iiinc Smith & Nephew, 36mm CoCr Femoral Heads K022902 10/2/02 In c ._ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _… | 2002 |
| * | K022958 | Total Hip Femoral Heads and LinersSummary page 1…_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Smith & Nephew, 36mm Oxinium Femoral Heads K022958 10/2/02 In c ._ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _… | 2002 |
| * | K896580 | Uni-Polar HeadSummary page 1…_ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ Smith & Nephew, UnplrFmrlHasK896580 2/15/90 Inc. UnplrFmrlHasK934353… | 1990 |
| * | K934353 | Zirconium Alloy Uni-Polar HeadSummary page 1…Smith & Nephew, UnplrFmrlHasK896580 2/15/90 Inc. UnplrFmrlHasK934353 4/25/94 Smith & Nephew, Modular Femoral (Hemni)… | 1994 |
| * | K062408 | Smith & Nephew Modular Femoral (Hemi) HeadSummary page 1…53 4/25/94 Smith & Nephew, Modular Femoral (Hemni) Heads K062408 9/12/06 Inc. Smith & Nephew, Relcin3Aetabular System… | 2006 |
| * | K061253 | Reflection 3 Acetabular SystemSummary page 1…s K062408 9/12/06 Inc. Smith & Nephew, Relcin3Aetabular System K061253 5/31/06 Inc. Relcin3K070756… | 2006 |
| * | K070756 | Smith and Nephew Reflection 3 Acetabular SystemSummary page 1…Inc. Smith & Nephew, Relcin3Aetabular System K061253 5/31/06 Inc. Relcin3K070756 6/6/07 Smith & Nephew, Reflection XLPE Ace… | 2007 |
| * | K071160 | Reflection, Tandem UnipolarSummary page 1…6/6/07 Smith & Nephew, Reflection XLPE Acetabular K07 1160 10/5/07 Inc. Liners Stryker Orthopaedics Trident Hip System… | 2007 |
| * | K061434 | Trident Large Diameter Hip SystemSummary page 1…K07 1160 10/5/07 Inc. Liners Stryker Orthopaedics Trident Hip System K06 1434 8/22/06 Depuy Orthopaedics, Pinnacle Altrx Acetabular Cup K062 148… | 2006 |
| * | K062148 | Depuy Pinnacle Altrx Acetabular Cup LinerSummary page 1…m K06 1434 8/22/06 Depuy Orthopaedics, Pinnacle Altrx Acetabular Cup K062 148 10/24/06 Inc. Liner__ _ _… | 2006 |
What descends from it? (16)
See all 167 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 12 of the 44 ancestors have a recall of any class.
- Of its descendants, K113848 (Smith & Nephew, Inc., 2012) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K022902.
How does its category compare?
All MBL devicesMBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MBL
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MBL
Too few MBL 510(k)s in any year since 2007 to give a median.
Recalls per year · MBL
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBL
41in 2025
MAUDE reports naming product code MBL, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 2 | 6 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 1 | 15 |
| 2015 | 0 | — | 0 | 55 |
| 2016 | 1 | — | 0 | 54 |
| 2017 | 0 | — | 0 | 61 |
| 2018 | 1 | — | 0 | 112 |
| 2019 | 0 | — | 0 | 172 |
| 2020 | 1 | — | 0 | 115 |
| 2021 | 1 | — | 0 | 116 |
| 2022 | 0 | — | 0 | 90 |
| 2023 | 0 | — | 0 | 78 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 0 | — | 0 | 41 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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 or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthiritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for…
Read the full statement (134 words)
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 or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthiritis, 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; 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 3 Acetabular System is for single use only and is intended for cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093363: Cocr and Oxinium Femoral Heads and R3 Xlpe Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093363
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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