510(k) · Cleared
ClearedPlus Fracture Head Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plus Orthopedics · KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Cleared on Mar 15, 1999 as substantially equivalent to K965156 (Johnson & Johnson Professionals, Inc., 1997) and 1 other predicate after a 42-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Mar 15, 1999
- Review
- 42 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K965156 (1997). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK965156 Ultima*Unipolar Head and Adapter SleevesJohnson & Johnson Professionals, Inc. · 1997
- This deviceK990309 Plus Fracture Head ProsthesisPlus Orthopedics · 1999
- Descendant · cites it directly · 0 of its ownK123598 Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K965156 | Ultima*Unipolar Head and Adapter Sleeves | Johnson & Johnson Professionals, Inc. | 1997 | — |
| 0 (this device) | K990309 | Plus Fracture Head Prosthesis | Plus Orthopedics | 1999 | — |
| +1 | K123598 | Smith & Nephew, Inc. Hip System Instrumentation | Smith & Nephew, Inc. | 2013 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 KWL? 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 KWL device
- #1 K253675 OsteoRemedies Hip Spacer Systemscore 16.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K965156 | Ultima*Unipolar Head and Adapter SleevesSummary page 1…Prosthesis, hip, femoral head Hip Joint Femoral (Hemi-Hip) Metallic Cemented or Uncemented Prosthesis 21 CFR 888.3360 (87 KWL) Johnson & Johnson ULTIMA Unipolar Head (K965156, SE date 01/24/97) and the Foundation Unipolar Femaral Head (K973614, SE date 12/18/97). The PLUS Fracture Head Prosthesis comes… | 1997 |
| * | K973614 | Foundation Unipolar Femoral Head with Modular Neck Length SleevesSummary page 1…Cemented or Uncemented Prosthesis 21 CFR 888.3360 (87 KWL) Johnson & Johnson ULTIMA Unipolar Head (K965156, SE date 01/24/97) and the Foundation Unipolar Femaral Head (K973614, SE date 12/18/97). The PLUS Fracture Head Prosthesis comes in 12 different sizes and in two neck lengths, The PLUS Fracture Hea… | 1997 |
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 |
|---|---|---|---|
| K123598 | Smith & Nephew, Inc. Hip System Instrumentation | 2013 | 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?
How does its category compare?
All KWL devicesKWL Prosthesis, Hip, Hemi-, Femoral, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWL
32in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWL
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWL
29in 2025
MAUDE reports naming product code KWL, 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 | — | 36 | 11 |
| 2008 | 1 | — | 0 | 13 |
| 2009 | 0 | — | 2 | 21 |
| 2010 | 0 | — | 0 | 55 |
| 2011 | 2 | — | 0 | 51 |
| 2012 | 1 | — | 0 | 62 |
| 2013 | 0 | — | 0 | 89 |
| 2014 | 0 | — | 0 | 107 |
| 2015 | 1 | — | 1 | 223 |
| 2016 | 0 | — | 0 | 210 |
| 2017 | 0 | — | 2 | 347 |
| 2018 | 2 | — | 0 | 294 |
| 2019 | 1 | — | 0 | 415 |
| 2020 | 1 | — | 0 | 270 |
| 2021 | 0 | — | 0 | 107 |
| 2022 | 1 | — | 0 | 99 |
| 2023 | 0 | — | 0 | 48 |
| 2024 | 1 | — | 0 | 143 |
| 2025 | 3 | 32 | 0 | 29 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The PLUS Fracture Head Prosthesis is intended for use in fractures of the femoral neck and fractures or avascular necrosis of the femoral head with all PLUS hip stem prostheses, which have the appropriate 12/14 Morse Taper.
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/K990309 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990309: Plus Fracture Head Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990309
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