510(k) · Cleared
ClearedP.F.C. Ceramic Hip Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Orthopaedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Sep 28, 1994 after a 449-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 13 later devices descend from it.
- Decided
- Sep 28, 1994
- Review
- 449 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK933275 P.F.C. Ceramic Hip HeadJohnson & Johnson Orthopaedics, Inc. · 1994
- Descendant · cites it directly · 12 of its ownK962248 P.F.C. Ceramic Hip HeadJohnson & Johnson Professionals, Inc. · 1996
- Descendant · cites it directly · 11 of its ownK973307 S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1997
- Descendant · 2 generations on · 10 of its ownK980081 S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1998
- Descendant · 3 generations on · 9 of its ownK990261 Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics · 1999
- Descendant · 4 generations on · 7 of its ownK012918 Apex Modular Alumina Femoral HeadApex Surgical, LLC · 2001
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K962248P.F.C. Ceramic Hip HeadJohnson & Johnson Professionals, Inc. · 1996 · cites it directly12descendants
- K973307S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1997 · cites it directly11descendants
- K980081S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1998 · 2 generations on10descendants
- K990261Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics · 1999 · 3 generations on9descendants
- K012918Apex Modular Alumina Femoral HeadApex Surgical, LLC · 2001 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933275 | P.F.C. Ceramic Hip Head | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| +1 | K962248 | P.F.C. Ceramic Hip Head | Johnson & Johnson Professionals, Inc. | 1996 | — |
| +1 | 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 | — |
| +3 | K990261 | Plus Ceramic Head Prostheses (Alumina and Zirkonia) | Plus Orthopedics | 1999 | — |
| +4 | K012918 | Apex Modular Alumina Femoral Head | Apex Surgical, LLC | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (13)
See all 132 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?
- Of its descendants, K962248 (Johnson & Johnson Professionals, Inc., 1996) has gone furthest, with 12 descendants of its own.
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 | — |
https://510kreport.com/device/K933275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K933275: P.F.C. Ceramic Hip Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933275
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026