510(k) · Cleared
ClearedReflection 3 Acetabular System
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 May 31, 2006 as substantially equivalent to K920430 (Smith & Nephew Richards, Inc., 1992) and 4 other predicates after a 27-day review. Its family tree reaches back 2 generations to 1986. 120 later devices descend from it.
- Decided
- May 31, 2006
- Review
- 27 days
- Class
- Class II
- Product code
- MBL
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K861766 (1986). 7 ancestors in all. 120 later devices descend from it, 11 citing it directly.
- Root · 2 generations backK861766 Howmedica Hoffmann Fixation Pin SystemHowmedica Corp. · 1986
- 1 generation backK964094 MinifixFerguson Medical · 1996
- This deviceK061253 Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006
- Descendant · cites it directly · 91 of its ownK070756 Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · Recalled
- Descendant · cites it directly · 46 of its ownK092386 R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc. · 2009
- Descendant · cites it directly · 35 of its ownK100933 Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc. · 2010
- Descendant · 2 generations on · 33 of its ownK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010
- Descendant · 2 generations on · 25 of its ownK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
Showing 5 of 120 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 120 · See all- K070756Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · cites it directly91descendants
- K092386R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc. · 2009 · cites it directly46descendants
- K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc. · 2010 · cites it directly35descendants
- K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010 · 2 generations on33descendants
- K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010 · 2 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K861766 | Howmedica Hoffmann Fixation Pin System | Howmedica Corp. | 1986 | — |
| −1 | K964094 | Minifix | Ferguson Medical | 1996 | — |
| 0 (this device) | K061253 | Reflection 3 Acetabular System | Smith & Nephew, Inc. | 2006 | — |
| +1 | K070756 | Smith and Nephew Reflection 3 Acetabular System | Smith & Nephew, Inc. | 2007 | 6 |
| +1 | K092386 | R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners | Smith & Nephew, Inc. | 2009 | — |
| +1 | K100933 | Consensus CS2 Plus Acetabular Insert | Consensus Orthopedics, Inc. | 2010 | — |
| +2 | K102399 | Consensus Taperset Hip System | Consensus Orthopedics, Inc. | 2010 | — |
| +2 | K100445 | Klassic HD Hip System | Total Joint Orthopedics, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 8 | 0 |
| 2012 | 10 | 0 |
| 2013 | 8 | 0 |
| 2014 | 5 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 11 | 0 |
| 2018 | 7 | 0 |
| 2019 | 7 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 10 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 8 | 0 |
| 2026 | 9 | 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? (5)
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 |
|---|---|---|---|
| * | K920430 | Modular Acetabular Cup SystemSummary page 1…ON 3 Acetabular System issupported by its similarities in design features, overall indications, and material composition to the RELFECTION Acetabular System (K920430. K932755, K9906661. the REFLECTION Interfit Shell (1K9640094, K9906661, and the lOMRad REFLECTION Acetabutar Liner (K(00274… | 1992 |
| * | K932755 | Reflection Acetabular ComponentSummary page 1…abular System issupported by its similarities in design features, overall indications, and material composition to the RELFECTION Acetabular System (K920430. K932755, K9906661. the REFLECTION Interfit Shell (1K9640094, K9906661, and the lOMRad REFLECTION Acetabutar Liner (K(002747) manufa… | 1994 |
| * | K990666 | Hydroxyapatite (HA) Reflection Acetabular Shell, Hydroxyapatite (HA) Reflection Interfit…Summary page 1…stem issupported by its similarities in design features, overall indications, and material composition to the RELFECTION Acetabular System (K920430. K932755, K9906661. the REFLECTION Interfit Shell (1K9640094, K9906661, and the lOMRad REFLECTION Acetabutar Liner (K(002747) manufactured an… | 1999 |
| * | K964094 | Minifix | 1996 |
| * | K002747 | Reflection Cross-Linked Uhmwpe Acetabular ComponentsSummary page 2…nt lo the RELFECTION Acetabutar System IK920430, K932755, K9906661. the REFLECTION Interfit Shell K9640094. K9906661, and the lOMRad REFLECTION Acetabular Liner iK002747). Design Control Activities have been completed and the results indicate that the subject device is safe and effe… | 2000 |
What descends from it? (120)
See all 12011 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070756 | Smith and Nephew Reflection 3 Acetabular System | 2007 | 91 |
| K092386 | R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners | 2009 | 46 |
| K100933 | Consensus CS2 Plus Acetabular Insert | 2010 | 35 |
| K092265 | Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners | 2010 | 23 |
| K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe Liners | 2010 | 16 |
| K122185 | U-Motion II Acetabular System | 2013 | 7 |
| K113848 | R3 Xlpe Liners | 2012 | 7 |
| K210614 | BENCOX Mirabo Z Cup Cortinium | 2022 | 1 |
| K092098 | Patient Specific Acetabular Reconstruction Prosthesis | 2010 | 1 |
| K201701 | R3 HA Coated Acetabular Shells | 2020 | 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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 10.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K070756 (Smith & Nephew, Inc., 2007) has gone furthest, with 91 descendants of its own.
- 5 other devices also cite its predicate K920430.
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.
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?
The REFLECTION 3 Acetabular System 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, inflammator joint disease such as rheumatoidathritis, or noninflammatory degenerative joint disease (NIDJD] or any of its composite diagnoses such as osteoarthritis: avasular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture…
Read the full statement (129 words)
The REFLECTION 3 Acetabular System 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, inflammator joint disease such as rheumatoidathritis, or noninflammatory degenerative joint disease (NIDJD] or any of its composite diagnoses such as osteoarthritis: avasular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant; old, remote osteomyetitis with an extended drainage-free period; non-union; femnoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteolomy; or Girdlestone resection: fracture dislocation of the hip; and correction of deformity.
The REFLECTION 3 Acetabular System is for single use only. The REFLECTION 3 Acetabutar System is intended for cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061253 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061253: Reflection 3 Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061253
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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