510(k) · Cleared
ClearedNexflex Total Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexmed, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Aug 5, 2004 after a 266-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Aug 5, 2004
- Review
- 266 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK033580 Nexflex Total Hip SystemNexmed, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK042252 Nexflex Total Hip SystemAlphatec/Nexmed · 2004
Most influential descendants
Showing 1 of 1 · See all- K042252Nexflex Total Hip SystemAlphatec/Nexmed · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033580 | Nexflex Total Hip System | Nexmed, Inc. | 2004 | — |
| +1 | K042252 | Nexflex Total Hip System | Alphatec/Nexmed | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042252 | Nexflex Total Hip System | 2004 | 0 |
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, K042252 (Alphatec/Nexmed, 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
1) When used as a hemi-hip replacement system, it is intended for osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal involvement of the corresponding acetabulum, femoral head or neck fractures, aseptic necrosis of the femoral head, previous failed hip arthroplasty where there is evidence of sufficient bone quality to adequately set the implant. 2) When used as a total hip replacement system, it is intended for osteo-, rheumatoid…
Read the full statement (174 words)
1) When used as a hemi-hip replacement system, it is intended for osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal involvement of the corresponding acetabulum, femoral head or neck fractures, aseptic necrosis of the femoral head, previous failed hip arthroplasty where there is evidence of sufficient bone quality to adequately set the implant.
2) When used as a total hip replacement system, it is intended for osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal involvement of the corresponding acetabulum, femoral head or neck fractures, aseptic necrosis of the femoral head, previous failed hip arthroplasty where there is evidence of sufficient bone quality to adequately set the implant.
3) In addition, the NexFlex Total Hip System is intended for cases where alternative modes of treatment appear less preferable and the associated risks of a total hip replacement are thought to be acceptable. It is intended for severely disabled joints, which could result from arthritis or late stages of avascular necrosis and revisions of unsuccessful acetabular cup arthroplasty an /or emoral procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033580 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033580: Nexflex Total Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033580
Report an extraction error
Are you the manufacturer?
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