510(k) · Cleared
ClearedQuatro M Femoral Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Whiteside Biomechanics, Inc. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Jul 28, 2004 as substantially equivalent to K964616 (Whiteside Biomechanics, Inc., 1997) after a 287-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jul 28, 2004
- Review
- 287 days
- Class
- Class II
- Product code
- LWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964616 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK964616 Quatroloc Plasma Sprayed Femoral ComponentWhiteside Biomechanics, Inc. · 1997
- This deviceK033313 Quatro M Femoral ComponentWhiteside Biomechanics, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964616 | Quatroloc Plasma Sprayed Femoral Component | Whiteside Biomechanics, Inc. | 1997 | — |
| 0 (this device) | K033313 | Quatro M Femoral Component | Whiteside Biomechanics, Inc. | 2004 | — |
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 LWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K964616 | Quatroloc Plasma Sprayed Femoral ComponentSummary page 1…Classification Panel: Class II Substantial Equivalence To: Quatroloc Plasma Spray Femoral Component (K964616) Device Description: The implant will consist of a solid, rectangularly cross-sectioned wrought titanium 6AL-4V (ASTM 1472) ste… | 1997 |
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?
- Its one ancestor has no recall.
How does its category compare?
All LWJ devicesLWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWJ
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · LWJ
Too few LWJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LWJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWJ
51in 2025
MAUDE reports naming product code LWJ, 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 | 2 | — | 10 | 68 |
| 2008 | 1 | — | 2 | 72 |
| 2009 | 1 | — | 2 | 84 |
| 2010 | 0 | — | 0 | 132 |
| 2011 | 1 | — | 0 | 255 |
| 2012 | 1 | — | 0 | 390 |
| 2013 | 0 | — | 1 | 522 |
| 2014 | 0 | — | 0 | 452 |
| 2015 | 0 | — | 0 | 310 |
| 2016 | 0 | — | 0 | 293 |
| 2017 | 0 | — | 0 | 311 |
| 2018 | 0 | — | 0 | 227 |
| 2019 | 0 | — | 0 | 210 |
| 2020 | 0 | — | 0 | 189 |
| 2021 | 0 | — | 0 | 155 |
| 2022 | 0 | — | 0 | 91 |
| 2023 | 0 | — | 2 | 72 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 0 | — | 0 | 51 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Quatro-M Plasma Spray Femoral Component is for press-fit, uncemented use It is intended to be used for:
Noninflammatory degenerative joint disease including osteoarthritis
2 Rheumatoid arthritis
3. Avascular necrosis
4. Correction of functional deformity
5. Revision procedures where other treatments or devices have failed
6. Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033313: Quatro M 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/K033313
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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