510(k) · Cleared
ClearedS-Rom Zirconia Ceramic Femoral Hip Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Professionals, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Apr 9, 1998 as substantially equivalent to K973307 (Johnson & Johnson Professionals, Inc., 1997) and 1 other predicate after a 90-day review. Its family tree reaches back 3 generations to 1994. 10 later devices descend from it.
- Decided
- Apr 9, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K933275 (1994). 4 ancestors in all, the oldest K921111 (1992). 10 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK933275 P.F.C. Ceramic Hip HeadJohnson & Johnson Orthopaedics, Inc. · 1994
- 2 generations backK962248 P.F.C. Ceramic Hip HeadJohnson & Johnson Professionals, Inc. · 1996
- 1 generation backK973307 S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1997
- This deviceK980081 S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1998
- Descendant · cites it directly · 9 of its ownK990261 Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics · 1999
- Descendant · 2 generations on · 7 of its ownK012918 Apex Modular Alumina Femoral HeadApex Surgical, LLC · 2001
- Descendant · 3 generations on · 4 of its ownK101451 Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc. · 2010
- Descendant · 4 generations on · 2 of its ownK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021
- Descendant · 5 generations on · 1 of its ownK241472 Icona Hip StemCorin U.S.A. Limited · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K990261Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics · 1999 · cites it directly9descendants
- K012918Apex Modular Alumina Femoral HeadApex Surgical, LLC · 2001 · 2 generations on7descendants
- K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc. · 2010 · 3 generations on4descendants
- K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd. · 2021 · 4 generations on2descendants
- K241472Icona Hip StemCorin U.S.A. Limited · 2024 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933275 | P.F.C. Ceramic Hip Head | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| −2 | 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 | — |
| 0 (this device) | 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 | — |
| +2 | K012918 | Apex Modular Alumina Femoral Head | Apex Surgical, LLC | 2001 | — |
| +3 | K101451 | Apex Module Hip System Biolox Delta Femoral Head | Omni Life Science, Inc. | 2010 | — |
| +4 | K201657 | Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular… | Corin, Ltd. | 2021 | — |
| +5 | K241472 | Icona Hip Stem | Corin U.S.A. Limited | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 |
|---|---|---|---|
| * | K973307 | S-Rom Zirconia Ceramic Femoral Hip HeadSummary page 1…rconia Ceramic Femoral Head is identical in design (drawing specifications) to the S-ROM Zirconia Ceramic Femoral Head cleared for marketing under premarket notification K973307 (November 20, 1997) for use with titanium alloy femoral components. The S-ROM Zirconia Ceramic Femoral Head is identical in mater… | 1997 |
| * | K921111 | S-Rom Zirconia Cermamic Femoral HeadSummary page 1…ic Femoral Head is identical in material (PROZYR® or ZYRANOX™) to the S-ROM Zirconia Ceramic Femoral Head cleared for marketing under premarket notifications K973307 and K921111. The subject device is to be utilized with the same 11/13 Morse-taper femoral components as the predicate device mentioned above… | 1992 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990261 | Plus Ceramic Head Prostheses (Alumina and Zirkonia) | 1999 | 9 |
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 4 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K990261 (Plus Orthopedics, 1999) has gone furthest, with 9 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 S-ROM Zirconia Ceramic Femoral Head is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and non-union of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped femoral epiphysis, and disability due to previous fusion.
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/K980081 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980081: S-Rom Zirconia Ceramic Femoral Hip Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980081
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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