510(k) · Cleared
Recalled · Class II · 2013United 36MM Ceramic Femoral Head, Delta
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Orthopedic Corporation · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Sep 23, 2011 as substantially equivalent to K103497 (United Orthopedic Corp., 2011) and 5 other predicates after a 28-day review. Its family tree reaches back 9 generations to 1981. 8 later devices descend from it. It has been recalled once.
- Decided
- Sep 23, 2011
- Review
- 28 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 9 generations to K810258 (1981). 40 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 5 generations between
- 3 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 2 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 1 generation backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- This deviceK112463 United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation · 2011
- Descendant · cites it directly · 7 of its ownK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
- Descendant · 2 generations on · 3 of its ownK163441 Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017
- Descendant · 2 generations on · 3 of its ownK132455 U-Motion II PS+ CupUnited Orthopedic Corp. · 2013
- Descendant · 2 generations on · 2 of its ownK172833 E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation · 2018
- Descendant · 2 generations on · 2 of its ownK170089 U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation · 2017
Show all 9 generations
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 7 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 6 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 5 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 4 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 3 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 2 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 1 generation backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- This deviceK112463 United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation · 2011
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K122185U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013 · cites it directly7descendants
- K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017 · 2 generations on3descendants
- K132455U-Motion II PS+ CupUnited Orthopedic Corp. · 2013 · 2 generations on3descendants
- K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation · 2018 · 2 generations on2descendants
- K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −8 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −7 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −6 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −5 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −4 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −3 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −2 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −1 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| 0 (this device) | K112463 | United 36MM Ceramic Femoral Head, Delta | United Orthopedic Corporation | 2011 | — |
| +1 | K122185 | U-Motion II Acetabular System | United Orthopedic Corp. | 2013 | — |
| +2 | K163441 | Locking Cage, Full XPE Cup | United Orthopedic Corporation | 2017 | — |
| +2 | K132455 | U-Motion II PS+ Cup | United Orthopedic Corp. | 2013 | — |
| +2 | K172833 | E-XPE Acetabular Components and U-Motion II Acetabular Cup | United Orthopedic Corporation | 2018 | — |
| +2 | K170089 | U-Motion II Acetabular System— Additional sizes | United Orthopedic Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K103497 | Ceramic Femoral HeadSummary page 1…ice Product Code: LZO, MEH, LPH Predicate Device: 1. "UNITED" Ceramic Femoral Head, manufactured by United Orthopedic Corporation, K103497, cleared March 04, 2011 2. Smith & Nephew BIOLOX®&… | 2011 |
| * | K083762 | Biolox Delta Ceramic Femoral HeadsSummary page 1…04, 2011 2. Smith & Nephew BIOLOX®& Delta Ceramic Femoral Heads (K083762, K1004 12) 3. BIOMET BIOLOX® Delta Ceramic Heads (K042091, K061312, K05141 1… | 2009 |
| * | K100412 | Biolox Delta Ceramic Femoral HeadsSummary page 1…1 2. Smith & Nephew BIOLOX®& Delta Ceramic Femoral Heads (K083762, K1004 12) 3. BIOMET BIOLOX® Delta Ceramic Heads (K042091, K061312, K05141 1) Device… | 2010 |
| * | K042091 | Biolox Delta Ceramic HeadsSummary page 1…Delta Ceramic Femoral Heads (K083762, K1004 12) 3. BIOMET BIOLOX® Delta Ceramic Heads (K042091, K061312, K05141 1) Device Description: "UNITED" 36 mm Ceramic Femoral Head - Delta is an addi… | 2005 |
| * | K061312 | 36MM Biolox Delta Ceramic HeadsSummary page 1…eramic Femoral Heads (K083762, K1004 12) 3. BIOMET BIOLOX® Delta Ceramic Heads (K042091, K061312, K05141 1) Device Description: "UNITED" 36 mm Ceramic Femoral Head - Delta is an additional size extension to the UOC-FDA… | 2006 |
| * | K051411 | Arcomxl Polyethylene Liners and Biolox Delta HeadsSummary page 1…moral Heads (K083762, K1004 12) 3. BIOMET BIOLOX® Delta Ceramic Heads (K042091, K061312, K05141 1) Device Description: "UNITED" 36 mm Ceramic Femoral Head - Delta is an additional size extension to the UOC-FDA -019… | 2005 |
What descends from it? (8)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2013 | Class II | Z-1386-2013 | Labeling design | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 11 of the 40 ancestors have a recall of any class.
- Of its descendants, K122185 (United Orthopedic Corp., 2013) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K103497.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
This device is indicated for use in total hip arthroplasty for the following conditions: painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques; revision procedures where other treatment or devices have failed arthroplasty or other procedure.
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/K112463 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112463: United 36MM Ceramic Femoral Head, Delta.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112463
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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