510(k) · Cleared
ClearedMallory/Head Smooth Femoral Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Feb 4, 2000 as substantially equivalent to K911684 (Biomet, Inc., 1991) and 2 other predicates after a 72-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Feb 4, 2000
- Review
- 72 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K911684 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK911684 Biomet Cobalt-Chrome Femoral ComponentsBiomet, Inc. · 1991 · Recalled
- This deviceK994007 Mallory/Head Smooth Femoral ComponentBiomet, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911684 | Biomet Cobalt-Chrome Femoral Components | Biomet, Inc. | 1991 | 12 |
| 0 (this device) | K994007 | Mallory/Head Smooth Femoral Component | Biomet, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1999 | 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? (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 |
|---|---|---|---|
| * | K911684 | Biomet Cobalt-Chrome Femoral ComponentsSummary page 2…n and design. Direct comparison was made with the following predicates: o Biomet Cobalt-Chrome Femoral Component (Mallory/Head Cemented Femoral) — (Biomet Inc. — 510(k) K911684) ¢ Rx 90 Hip System — (Biomet Inc. — 510(k) K942028) ¢ Color Buffed Cemented Femoral — (Biomet Inc. — 510(k) K992903) 100052… | 1991 |
| * | K942028 | RX90 Femoral ComponentSummary page 2…lowing predicates: o Biomet Cobalt-Chrome Femoral Component (Mallory/Head Cemented Femoral) — (Biomet Inc. — 510(k) K911684) ¢ Rx 90 Hip System — (Biomet Inc. — 510(k) K942028) ¢ Color Buffed Cemented Femoral — (Biomet Inc. — 510(k) K992903) 100052 S Rt 5 ) antny, o, %, ‘-/é DEPARTM… | 1994 |
| * | K992903 | Color Buffed Cemented FemoralSummary page 2…ory/Head Cemented Femoral) — (Biomet Inc. — 510(k) K911684) ¢ Rx 90 Hip System — (Biomet Inc. — 510(k) K942028) ¢ Color Buffed Cemented Femoral — (Biomet Inc. — 510(k) K992903) 100052 S Rt 5 ) antny, o, %, ‘-/é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service —d Food and… | 1999 |
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?
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K911684.
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 Mallory/ Head Smooth femoral component is indicated for:
1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2) Rheumatoid arthritis
3) Correction of functional deformity
4) Revision procedures where other treatment or devices have failed
5) Treatment of nonunions, which are femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
This device is for use with bone cement.
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/K994007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994007: Mallory/Head Smooth Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994007
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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