510(k) · Cleared
ClearedRX 90 Femoral Stem and RX 90 Lateralized Femoral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Orthopedics, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Oct 17, 2002 after a 30-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 13 later devices descend from it.
- Decided
- Oct 17, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 1
13 later devices descend from it, 2 citing it directly.
- This deviceK023085 RX 90 Femoral Stem and RX 90 Lateralized Femoral StemBiomet Orthopedics, Inc. · 2002
- Descendant · cites it directly · 12 of its ownK031734 Generation 4 Polished Femoral Hip ProsthesisBiomet, Inc. · 2003
- Descendant · cites it directly · 11 of its ownK052639 Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement…Biomet Manufacturing, Inc. · 2006
- Descendant · 2 generations on · 10 of its ownK130610 Sirius Femoral StemBiomet, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 9 of its ownK142295 Sirius Femoral Stem, Size 30ABiomet, Inc. · 2014
- Descendant · 3 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K031734Generation 4 Polished Femoral Hip ProsthesisBiomet, Inc. · 2003 · cites it directly12descendants
- K052639Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement SpacerBiomet Manufacturing, Inc. · 2006 · cites it directly11descendants
- K130610Sirius Femoral StemBiomet, Inc. · 2013 · 2 generations on10descendants
- K142295Sirius Femoral Stem, Size 30ABiomet, Inc. · 2014 · 3 generations on9descendants
- K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023085 | RX 90 Femoral Stem and RX 90 Lateralized Femoral Stem | Biomet Orthopedics, Inc. | 2002 | — |
| +1 | K031734 | Generation 4 Polished Femoral Hip Prosthesis | Biomet, Inc. | 2003 | — |
| +1 | K052639 | Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement Spacer | Biomet Manufacturing, Inc. | 2006 | — |
| +2 | K130610 | Sirius Femoral Stem | Biomet, Inc. | 2013 | 2 |
| +3 | K142295 | Sirius Femoral Stem, Size 30A | Biomet, Inc. | 2014 | — |
| +3 | K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | Stryker Orthopaedics | 2018 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K924028 | FDA’s K924028 is Laparoscopic Surgical Instrument Our reading of the summary gave K924028, FDA’s number for Laparoscopic Surgical Instrument (Jana Medical). Its FDA name has none of the distinctive words the summary uses for the device it names, “Rx 90TM Femoral Components”. Kept off the family tree. Summary page 1…rained cemented prosthesis Device Classification: Class I1 Legally hlarketed Device to which Substantially Equivalence is Claimed: Rx goTh1 Femoral Components- 5 1O(k) K924028 Device Description: The Rx goTh1Femoral Components have been modified to include, not only a lateralized version to expand its p… | 1993 |
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, K031734 (Biomet, Inc., 2003) has gone furthest, with 12 descendants of its own.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The indications for the Rx 90TM Femoral Stems and Rx 90TM Lateralized Femoral Stems are for 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Correction of functional deformity; 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5) Revision procedures where other treatments or devices have failed.
This device is to be used with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023085 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023085: RX 90 Femoral Stem and RX 90 Lateralized Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023085
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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