510(k) · Cleared
ClearedPlus Ceramic Head Prostheses (Alumina and Zirkonia)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plus Orthopedics · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Aug 27, 1999 as substantially equivalent to K965002 (Encore Orthopedics, Inc., 1997) and 3 other predicates after a 212-day review. Its family tree reaches back 4 generations to 1994. 9 later devices descend from it.
- Decided
- Aug 27, 1999
- Review
- 212 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K933275 (1994). 23 ancestors in all, the oldest K823727 (1983). 9 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK933275 P.F.C. Ceramic Hip HeadJohnson & Johnson Orthopaedics, Inc. · 1994
- 3 generations backK962248 P.F.C. Ceramic Hip HeadJohnson & Johnson Professionals, Inc. · 1996
- 2 generations backK973307 S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1997
- 1 generation backK980081 S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1998
- This deviceK990261 Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics · 1999
- Descendant · cites it directly · 7 of its ownK012918 Apex Modular Alumina Femoral HeadApex Surgical, LLC · 2001
- Descendant · 2 generations on · 4 of its ownK101451 Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc. · 2010
- Descendant · 3 generations on · 2 of its ownK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021
- Descendant · 4 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
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K012918Apex Modular Alumina Femoral HeadApex Surgical, LLC · 2001 · cites it directly7descendants
- K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc. · 2010 · 2 generations on4descendants
- K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd. · 2021 · 3 generations on2descendants
- K241472Icona Hip StemCorin U.S.A. Limited · 2024 · 4 generations on1descendant
- K042035Alumina HeadFournitures Hospitalieres Industrie · 2004 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933275 | P.F.C. Ceramic Hip Head | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| −3 | K962248 | P.F.C. Ceramic Hip Head | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −2 | K973307 | S-Rom Zirconia Ceramic Femoral Hip Head | Johnson & Johnson Professionals, Inc. | 1997 | — |
| −1 | K980081 | S-Rom Zirconia Ceramic Femoral Hip Head | Johnson & Johnson Professionals, Inc. | 1998 | — |
| 0 (this device) | K990261 | Plus Ceramic Head Prostheses (Alumina and Zirkonia) | Plus Orthopedics | 1999 | — |
| +1 | K012918 | Apex Modular Alumina Femoral Head | Apex Surgical, LLC | 2001 | — |
| +2 | K101451 | Apex Module Hip System Biolox Delta Femoral Head | Omni Life Science, Inc. | 2010 | — |
| +3 | K201657 | Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular… | Corin, Ltd. | 2021 | — |
| +4 | K241472 | Icona Hip Stem | Corin U.S.A. Limited | 2024 | — |
| +1 | K042035 | Alumina Head | Fournitures Hospitalieres Industrie | 2004 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (4)
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 |
|---|---|---|---|
| * | K965002 | Zirconia Ceramic Femoral Heads with Foundation Forged, Textured and Porous Stems, the…Summary page 1…Joint Metal/Ceramic/Polymer Semi-Constrained Cemented or Non- Porous Uncemented Prosthesis, 21 CFR 888.3353 (87 LZ0) Zirconia Ceramic Femoral Heads, Encore Orthopedics (K965002, SE 06/27/97). the S-ROM Zirconia Ceramic Femoral Head, Johnson & Johnson Professional (K980081, SE 04/09/98}, the Biolox Alumina… | 1997 |
| * | K980081 | S-Rom Zirconia Ceramic Femoral Hip HeadSummary page 1…FR 888.3353 (87 LZ0) Zirconia Ceramic Femoral Heads, Encore Orthopedics (K965002, SE 06/27/97). the S-ROM Zirconia Ceramic Femoral Head, Johnson & Johnson Professional (K980081, SE 04/09/98}, the Biolox Alumina Ceramic Femoral Head, Smith & Nephew (K981847, SE 07/17/98), the Alumina C-Taper Head, Osteonic… | 1998 |
| * | K981847 | Biolox Alumina Ceramic Femoral HeadSummary page 1…2, SE 06/27/97). the S-ROM Zirconia Ceramic Femoral Head, Johnson & Johnson Professional (K980081, SE 04/09/98}, the Biolox Alumina Ceramic Femoral Head, Smith & Nephew (K981847, SE 07/17/98), the Alumina C-Taper Head, Osteonics (K971409, SE 07/09/87). The INTRAPLANT Ceramic Head Prostheses are manufactur… | 1998 |
| * | K971409 | Osteonics Alumina C-Taper HeadSummary page 1…hnson & Johnson Professional (K980081, SE 04/09/98}, the Biolox Alumina Ceramic Femoral Head, Smith & Nephew (K981847, SE 07/17/98), the Alumina C-Taper Head, Osteonics (K971409, SE 07/09/87). The INTRAPLANT Ceramic Head Prostheses are manufactured by METOXIT AG (alumina and zirconia). Both come with the… | 1997 |
What descends from it? (9)
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 5 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 23 ancestors has a recall.
- Of its descendants, K012918 (Apex Surgical, LLC, 2001) has gone furthest, with 7 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 | — |
What is it indicated for?
The INTRAPLANT Ceramic Head Prostheses is intended for use in total hip arthroplasty. The indications for use of the total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedure where previous treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.
The INTRAPLANT Ceramic Head Prostheses are to be used only with SL-PLUS® and SLR-PLUS® hip stems.
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/K990261 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990261: Plus Ceramic Head Prostheses (Alumina and Zirkonia).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990261
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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