510(k) · Cleared
ClearedApex Modular Alumina Femoral Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apex Surgical, LLC · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Nov 27, 2001 as substantially equivalent to K981847 (Smith & Nephew, Inc., 1998) and 2 other predicates after an 89-day review. Its family tree reaches back 5 generations to 1994. 7 later devices descend from it.
- Decided
- Nov 27, 2001
- Review
- 89 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K933275 (1994). 25 ancestors in all, the oldest K823727 (1983). 7 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK933275 P.F.C. Ceramic Hip HeadJohnson & Johnson Orthopaedics, Inc. · 1994
- 4 generations backK962248 P.F.C. Ceramic Hip HeadJohnson & Johnson Professionals, Inc. · 1996
- 3 generations backK973307 S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1997
- 2 generations backK980081 S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1998
- 1 generation backK990261 Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics · 1999
- This deviceK012918 Apex Modular Alumina Femoral HeadApex Surgical, LLC · 2001
- Descendant · cites it directly · 4 of its ownK101451 Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc. · 2010
- Descendant · 2 generations on · 2 of its ownK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021
- Descendant · 3 generations on · 1 of its ownK241472 Icona Hip StemCorin U.S.A. Limited · 2024
- Descendant · cites it directly · 1 of its ownK042035 Alumina HeadFournitures Hospitalieres Industrie · 2004
- Descendant · 4 generations on · 0 of its ownK261576 Icona Hip StemCorin, Ltd. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc. · 2010 · cites it directly4descendants
- K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd. · 2021 · 2 generations on2descendants
- K241472Icona Hip StemCorin U.S.A. Limited · 2024 · 3 generations on1descendant
- K042035Alumina HeadFournitures Hospitalieres Industrie · 2004 · cites it directly1descendant
- K261576Icona Hip StemCorin, Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933275 | P.F.C. Ceramic Hip Head | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| −4 | K962248 | P.F.C. Ceramic Hip Head | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −3 | K973307 | S-Rom Zirconia Ceramic Femoral Hip Head | Johnson & Johnson Professionals, Inc. | 1997 | — |
| −2 | K980081 | S-Rom Zirconia Ceramic Femoral Hip Head | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −1 | K990261 | Plus Ceramic Head Prostheses (Alumina and Zirkonia) | Plus Orthopedics | 1999 | — |
| 0 (this device) | K012918 | Apex Modular Alumina Femoral Head | Apex Surgical, LLC | 2001 | — |
| +1 | K101451 | Apex Module Hip System Biolox Delta Femoral Head | Omni Life Science, Inc. | 2010 | — |
| +2 | K201657 | Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular… | Corin, Ltd. | 2021 | — |
| +3 | K241472 | Icona Hip Stem | Corin U.S.A. Limited | 2024 | — |
| +1 | K042035 | Alumina Head | Fournitures Hospitalieres Industrie | 2004 | — |
| +4 | K261576 | Icona Hip Stem | Corin, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 2 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K981847 | Biolox Alumina Ceramic Femoral HeadSummary page 2…Femoral Head to these predicate devices. Apex Modular" Smith & Plus Alumina Nephew Biolox Orthopedics Femoral Head Alumina Biolox® forte Ceramic Heads | Alumina Heads (K981847 and (K990261) K991162) INTENDED USE Primary and revision Yes Yes Yes total hip replacement DESIGN Taper design 12/14 12/14 12/14… | 1998 |
| * | K991162 | Biolox Alumina Ceramic Femoral HeadSummary page 2…predicate devices. Apex Modular" Smith & Plus Alumina Nephew Biolox Orthopedics Femoral Head Alumina Biolox® forte Ceramic Heads | Alumina Heads (K981847 and (K990261) K991162) INTENDED USE Primary and revision Yes Yes Yes total hip replacement DESIGN Taper design 12/14 12/14 12/14 Head diameters 28 and… | 2000 |
| * | K990261 | Plus Ceramic Head Prostheses (Alumina and Zirkonia)Summary page 2…to these predicate devices. Apex Modular" Smith & Plus Alumina Nephew Biolox Orthopedics Femoral Head Alumina Biolox® forte Ceramic Heads | Alumina Heads (K981847 and (K990261) K991162) INTENDED USE Primary and revision Yes Yes Yes total hip replacement DESIGN Taper design 12/14 12/14 12/14 Head diameter… | 1999 |
What descends from it? (7)
3 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 7 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 25 ancestors has a recall.
- Of its descendants, K101451 (Omni Life Science, Inc., 2010) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K981847.
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.
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?
The Apex Modular™ Alumina Femoral Head is intended for use in combination with the Apex Modular Hip Stem as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with a polyethylene or metal-backed polyethylene acetabular cup component. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease…
Read the full statement (96 words)
The Apex Modular™ Alumina Femoral Head is intended for use in combination with the Apex Modular Hip Stem as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with a polyethylene or metal-backed polyethylene acetabular cup component. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:
Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
Rheumatoid arthritis;
Correction of functional deformity;
Congenital dislocation;
Revision procedures where other treatments or devices have failed;
Femoral neck and trochanteric fractures of the proximal femur.
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/K012918 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012918: Apex Modular Alumina Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012918
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026