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 Nov 20, 1997 as substantially equivalent to K962248 (Johnson & Johnson Professionals, Inc., 1996) and 2 other predicates after a 78-day review. Its family tree reaches back 2 generations to 1994. 11 later devices descend from it.
- Decided
- Nov 20, 1997
- Review
- 78 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K933275 (1994). 3 ancestors in all, the oldest K921111 (1992). 11 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK933275 P.F.C. Ceramic Hip HeadJohnson & Johnson Orthopaedics, Inc. · 1994
- 1 generation backK962248 P.F.C. Ceramic Hip HeadJohnson & Johnson Professionals, Inc. · 1996
- This deviceK973307 S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1997
- Descendant · cites it directly · 10 of its ownK980081 S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1998
- Descendant · 2 generations on · 9 of its ownK990261 Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics · 1999
- Descendant · 3 generations on · 7 of its ownK012918 Apex Modular Alumina Femoral HeadApex Surgical, LLC · 2001
- Descendant · 4 generations on · 4 of its ownK101451 Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc. · 2010
- Descendant · 5 generations on · 2 of its ownK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K980081S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1998 · cites it directly10descendants
- K990261Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics · 1999 · 2 generations on9descendants
- K012918Apex Modular Alumina Femoral HeadApex Surgical, LLC · 2001 · 3 generations on7descendants
- K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc. · 2010 · 4 generations on4descendants
- K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd. · 2021 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | 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 | — |
| +2 | K990261 | Plus Ceramic Head Prostheses (Alumina and Zirkonia) | Plus Orthopedics | 1999 | — |
| +3 | K012918 | Apex Modular Alumina Femoral Head | Apex Surgical, LLC | 2001 | — |
| +4 | K101451 | Apex Module Hip System Biolox Delta Femoral Head | Omni Life Science, Inc. | 2010 | — |
| +5 | K201657 | Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular… | Corin, Ltd. | 2021 | — |
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 |
|---|---|---|
| 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), 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 |
|---|---|---|---|
| * | K962248 | P.F.C. Ceramic Hip HeadSummary page 1…ip Head is identical in material (PROZYR®) and in function (indicated use) to the P.F.C. Zirconia Ceramic Hip Head cleared for marketing under premarket notifications K# 962248 (August 29, 1996)/ K# 933275 (September 28, 1994). The S-ROM Zirconia Ceramic Hip Head is identical in design (drawing specifica… | 1996 |
| * | K933275 | P.F.C. Ceramic Hip HeadSummary page 1…ial (PROZYR®) and in function (indicated use) to the P.F.C. Zirconia Ceramic Hip Head cleared for marketing under premarket notifications K# 962248 (August 29, 1996)/ K# 933275 (September 28, 1994). The S-ROM Zirconia Ceramic Hip Head is identical in design (drawing specifications) and function (indicate… | 1994 |
| * | K921111 | S-Rom Zirconia Cermamic Femoral HeadSummary page 1…is identical in design (drawing specifications) and function (indicated use) to the S-ROM Zirconia Ceramic Hip Head cleared for marketing under premarket notification K# 921111. The subject device is composed of similar materials to the predicate device mentioned above (P.F.C. Zirconia Ceramic Hip Head).… | 1992 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980081 | S-Rom Zirconia Ceramic Femoral Hip Head | 1998 | 10 |
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 3 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K980081 (Johnson & Johnson Professionals, Inc., 1998) has gone furthest, with 10 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, traumatic 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/K973307 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973307: 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/K973307
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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