510(k) · Cleared
ClearedAlumina Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fournitures Hospitalieres Industrie · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on May 11, 2005 as substantially equivalent to K042035 (Fournitures Hospitalieres Industrie, 2004) and 1 other predicate after a 69-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- May 11, 2005
- Review
- 69 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K933275 (1994). 34 ancestors in all, the oldest K823727 (1983). No later device cites it as a predicate yet.
- Root · 7 generations backK933275 P.F.C. Ceramic Hip HeadJohnson & Johnson Orthopaedics, Inc. · 1994
- 6 generations backK962248 P.F.C. Ceramic Hip HeadJohnson & Johnson Professionals, Inc. · 1996
- 5 generations backK973307 S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1997
- 4 generations backK980081 S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1998
- 3 generations backK990261 Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics · 1999
- 2 generations backK012918 Apex Modular Alumina Femoral HeadApex Surgical, LLC · 2001
- 1 generation backK042035 Alumina HeadFournitures Hospitalieres Industrie · 2004
- This deviceK050556 Alumina HeadFournitures Hospitalieres Industrie · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933275 | P.F.C. Ceramic Hip Head | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| −6 | K962248 | P.F.C. Ceramic Hip Head | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −5 | K973307 | S-Rom Zirconia Ceramic Femoral Hip Head | Johnson & Johnson Professionals, Inc. | 1997 | — |
| −4 | 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 | — |
| −2 | K012918 | Apex Modular Alumina Femoral Head | Apex Surgical, LLC | 2001 | — |
| −1 | K042035 | Alumina Head | Fournitures Hospitalieres Industrie | 2004 | — |
| 0 (this device) | K050556 | Alumina Head | Fournitures Hospitalieres Industrie | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 2 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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? (2)
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 |
|---|---|---|---|
| * | K042035 | Alumina HeadSummary page 2…e have selected two predicate devices based upon intended uses, material used in device manufacturing and design features. These predicate devices are: - Alumina Head (K042035), F.H. Industrie - ESOP® Co-Cr femoral head (K021109), F.H. Industrie COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: Our alumina… | 2004 |
| * | K021109 | Esop CO-CR Femoral HeadsSummary page 2…ded uses, material used in device manufacturing and design features. These predicate devices are: - Alumina Head (K042035), F.H. Industrie - ESOP® Co-Cr femoral head (K021109), F.H. Industrie COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: Our alumina heads have the same intended use and substantial simi… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 34 ancestors has a recall of any class.
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?
Prosthetic replacement of the femoral head associated with a hip prosthesis having a taper compatible with the head taper, and with a prosthetic-acetabulum having an inside diameter compatible with that of the head. The alumina head can only be used with polyethylene inserts. This prothesis may be used for degenerative joint disease such as osteoarthritis and avascular necrosis, correction of functional deformity, rheumatoid arthritis, revision procedure where other devices or treatments have failed, congenital dislocation, femoral neck and trochanteric fractures, traumatic arthritis, fused hip, diastrophic variant, slipped capital epiphysis, non-union.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050556: Alumina Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050556
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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