510(k) · Cleared
Recalled · Class II · 2024TANDEM Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Cleared on Jul 19, 2023 as substantially equivalent to K896580 (Richards Medical Co., Inc., 1990) and 2 other predicates after a 62-day review. Its family tree reaches back 10 generations to 1981. It has been recalled once.
- Decided
- Jul 19, 2023
- Review
- 62 days
- Class
- Class II
- Product code
- LZY
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 10 generations to K810258 (1981). 178 ancestors in all, the oldest K791125 (1979). No later device cites it as a predicate yet.
- Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 6 generations between
- 3 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 2 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 1 generation backK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
- This deviceK231448 TANDEM Hip SystemSmith & Nephew, Inc. · 2023
Show all 10 generations
- Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 9 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 8 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 7 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 6 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 5 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 4 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 3 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 2 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 1 generation backK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
- This deviceK231448 TANDEM Hip SystemSmith & Nephew, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −9 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −8 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −7 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −6 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −5 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −4 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −3 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −2 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −1 | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | 1 |
| 0 (this device) | K231448 | TANDEM Hip System | Smith & Nephew, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1983 | 3 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 3 | 0 |
| 1992 | 6 | 0 |
| 1993 | 3 | 0 |
| 1994 | 15 | 0 |
| 1995 | 6 | 0 |
| 1996 | 12 | 0 |
| 1997 | 11 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 9 | 0 |
| 2001 | 2 | 0 |
| 2002 | 11 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 9 | 0 |
| 2006 | 7 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 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 LZY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K896580 | Uni-Polar HeadSummary page 4…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K896580 TANDEM UNI-POLAR Hip System LZY K023743… | 1990 |
| * | K023743 | Smith & Nephew Global Bipolar SystemSummary page 4…Product Code K896580 TANDEM UNI-POLAR Hip System LZY K023743 TANDEM International Bipolar Hip System KWY K211176… | 2003 |
| * | K211176 | Smith & Nephew Hip SystemsSummary page 4…LZY K023743 TANDEM International Bipolar Hip System KWY K211176 Smith & Nephew Hip System LPH Device Descri… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 15, 2024 | Class II | Z-0326-2025 | Under Investigation by firm | The Bipolar assembly contains an oversized Retainer Ring. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 42 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 44 of the 177 ancestors have a recall of any class.
- 7 other devices also cite its predicate K896580.
How does its category compare?
All LZY devicesLZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · LZY
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LZY
Too few LZY 510(k)s in any year since 2007 to give a median.
Recalls per year · LZY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZY
74in 2025
MAUDE reports naming product code LZY, 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 | 0 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 0 | — | 1 | 20 |
| 2010 | 0 | — | 0 | 38 |
| 2011 | 1 | — | 0 | 43 |
| 2012 | 0 | — | 0 | 46 |
| 2013 | 0 | — | 0 | 44 |
| 2014 | 0 | — | 0 | 46 |
| 2015 | 0 | — | 0 | 97 |
| 2016 | 0 | — | 0 | 76 |
| 2017 | 0 | — | 0 | 72 |
| 2018 | 0 | — | 0 | 67 |
| 2019 | 0 | — | 0 | 59 |
| 2020 | 0 | — | 0 | 79 |
| 2021 | 0 | — | 0 | 59 |
| 2022 | 0 | — | 0 | 65 |
| 2023 | 1 | — | 0 | 77 |
| 2024 | 0 | — | 0 | 74 |
| 2025 | 0 | — | 1 | 74 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Smith & Nephew TANDEM Unipolar and Bipolar Hip System is intended for partial hip arthroplasty in skeletally mature patients. It is indicated for use in patients not suitable for total hip arthroplasty, with a non-functional femoral head due to femoral neck fracture.
The TANDEM Unipolar and Bipolar head components are intended to articulate against the natural acetabulum, which requires no use of bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231448: TANDEM Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231448
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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