510(k) · Cleared
Recalled · Class II · 2020Smith and Nephew Reflection 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 Jun 6, 2007 as substantially equivalent to K061253 (Smith & Nephew, Inc., 2006) after a 78-day review. Its family tree reaches back 3 generations to 1986. 91 later devices descend from it. It has been recalled 6 times.
- Decided
- Jun 6, 2007
- Review
- 78 days
- Class
- Class II
- Product code
- MBL
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 3 generations to K861766 (1986). 8 ancestors in all. 91 later devices descend from it, 15 citing it directly.
- Root · 3 generations backK861766 Howmedica Hoffmann Fixation Pin SystemHowmedica Corp. · 1986
- 2 generations backK964094 MinifixFerguson Medical · 1996
- 1 generation backK061253 Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006
- This deviceK070756 Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007
- Descendant · cites it directly · 46 of its ownK092386 R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc. · 2009
- Descendant · 2 generations on · 25 of its ownK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
- Descendant · cites it directly · 21 of its ownK103721 Mpact Acetabular SystemMedacta International · 2011
- Descendant · 3 generations on · 16 of its ownK143407 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2014
- Descendant · cites it directly · 16 of its ownK093363 Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010
Showing 5 of 91 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 91 · See all- K092386R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc. · 2009 · cites it directly46descendants
- K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010 · 2 generations on25descendants
- K103721Mpact Acetabular SystemMedacta International · 2011 · cites it directly21descendants
- K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2014 · 3 generations on16descendants
- K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010 · cites it directly16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K861766 | Howmedica Hoffmann Fixation Pin System | Howmedica Corp. | 1986 | — |
| −2 | K964094 | Minifix | Ferguson Medical | 1996 | — |
| −1 | K061253 | Reflection 3 Acetabular System | Smith & Nephew, Inc. | 2006 | — |
| 0 (this device) | K070756 | Smith and Nephew Reflection 3 Acetabular System | Smith & Nephew, Inc. | 2007 | — |
| +1 | K092386 | R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners | Smith & Nephew, Inc. | 2009 | — |
| +2 | K100445 | Klassic HD Hip System | Total Joint Orthopedics, Inc. | 2010 | — |
| +1 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
| +3 | K143407 | Klassic HD Hip System | Total Joint Othopedics, Inc. | 2014 | — |
| +1 | K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe Liners | Smith & Nephew, 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 6 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 9 | 0 |
| 2018 | 7 | 0 |
| 2019 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 9 | 0 |
| 2023 | 7 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 7 | 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? (1)
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 |
|---|---|---|---|
| * | K061253 | Reflection 3 Acetabular SystemSummary page 1…ed from titanium alloy. The design of the shells and liners are similar to the REFLECTION 3 Acetabular Shell, the 10MRad REFLECTION 3 Acetabular Liner cleared under K061253 and the DePuy Pinnacle Acetabular Shell cleared under K033273. The REFLECTION 3 liners are manufactured from cross-link… | 2006 |
| † | K920430 | Modular Acetabular Cup System | 1992 |
| † | K932755 | Reflection Acetabular Component | 1994 |
| † | K990666 | Hydroxyapatite (HA) Reflection Acetabular Shell, Hydroxyapatite (HA) Reflection Interfit… | 1999 |
| † | K964094 | Minifix | 1996 |
| † | K002747 | Reflection Cross-Linked Uhmwpe Acetabular Components | 2000 |
| † | K033273 | Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima… | 2004 |
What descends from it? (91)
See all 9115 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092386 | R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners | 2009 | 46 |
| K103721 | Mpact Acetabular System | 2011 | 21 |
| K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe Liners | 2010 | 16 |
| K150790 | REDAPT Porous Acetabular Shell and Cemented Liner | 2015 | 13 |
| K111546 | U2 Hip System | 2011 | 13 |
| K122185 | U-Motion II Acetabular System | 2013 | 7 |
| K113848 | R3 Xlpe Liners | 2012 | 7 |
| K102370 | R3 Xlpe Anteverted Liners | 2011 | 6 |
| K211176 | Smith & Nephew Hip Systems | 2022 | 3 |
| K213842 | ONVOY Acetabular System | 2022 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 22, 2020 | Class II | Z-2332-2020 | Process control | A manufacturing error resulted in out of specification R3 Acetabular Shells |
| Apr 22, 2020 | Class II | Z-2334-2020 | Process control | A manufacturing error resulted in out of specification R3 Acetabular Shells |
| Apr 22, 2020 | Class II | Z-2335-2020 | Process control | A manufacturing error resulted in out of specification R3 Acetabular Shells |
| Apr 22, 2020 | Class II | Z-2336-2020 | Process control | A manufacturing error resulted in out of specification R3 Acetabular Shells |
| Apr 22, 2020 | Class II | Z-2331-2020 | Process control | A manufacturing error resulted in out of specification R3 Acetabular Shells |
| Apr 22, 2020 | Class II | Z-2333-2020 | Process control | A manufacturing error resulted in out of specification R3 Acetabular Shells |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K092386 (Smith & Nephew, Inc., 2009) has gone furthest, with 46 descendants of its own.
- 10 other devices also cite its predicate K061253.
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. 2007, 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?
The Smith & Nephew REFLECTION 3 is indicated for the following: * Non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis; * Rheumatoid arthritis; * Slipped capital epiphysis; * Fused hip; * Fracture of the pelvis and diastrophic variant; * Old, remote osteomyelitis with an extended drainage-free period; * Revision procedures where other treatments have failed; and * Treatment…
Read the full statement (123 words)
The Smith & Nephew REFLECTION 3 is indicated for the following:
* Non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis;
* Rheumatoid arthritis;
* Slipped capital epiphysis;
* Fused hip;
* Fracture of the pelvis and diastrophic variant;
* Old, remote osteomyelitis with an extended drainage-free period;
* 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 that are unmanageable using other techniques;
* Femoral osteotomy;
* Girdlestone resection;
* Fracture dislocation of the hip and;
* Correction of deformity
The REFLECTION 3 Acetabular System is for single use only. The REFLECTION 3 Acetabular System is intended for cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070756 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070756: Smith and Nephew Reflection 3 Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070756
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