510(k) · Cleared
ClearedAccu-Joint Hemi Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accufix Surgical, Inc. · KWD Prosthesis, Toe, Hemi-, Phalangeal
Cleared on Feb 29, 2024 as substantially equivalent to K200951 (Accufix Surgical, Inc., 2020) after a 29-day review. Its family tree reaches back 11 generations to 1987.
- Decided
- Feb 29, 2024
- Review
- 29 days
- Class
- Class II
- Product code
- KWD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K864492 (1987). 28 ancestors in all, the oldest K781870 (1979). No later device cites it as a predicate yet.
- Root · 11 generations backK864492 Swanson Titanium Great Toe ImplantDow Corning Wright · 1987 · Recalled
- 7 generations between
- 3 generations backK152454 HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. · 2016
- 2 generations backK190543 Cannulated Hemi ImplantVilex IN Tennessee, Inc. · 2019
- 1 generation backK200951 Accu-Joint Hemi ImplantAccufix Surgical, Inc. · 2020
- This deviceK240268 Accu-Joint Hemi ImplantAccufix Surgical, Inc. · 2024
Show all 11 generations
- Root · 11 generations backK864492 Swanson Titanium Great Toe ImplantDow Corning Wright · 1987 · Recalled
- 10 generations backK971047 Futura Biomedical Metal Hemi Toe ImplantNexa Orthopedics, Inc. · 1997
- 9 generations backK031859 Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2004
- 8 generations backK063370 Cap 7.0MM MTP Resurfacing Hemi-ArthroplastyArthrosurface, Inc. · 2007
- 7 generations backK073065 Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008
- 6 generations backK081876 Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP · 2008
- 5 generations backK102401 Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011
- 4 generations backK131377 Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2013
- 3 generations backK152454 HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. · 2016
- 2 generations backK190543 Cannulated Hemi ImplantVilex IN Tennessee, Inc. · 2019
- 1 generation backK200951 Accu-Joint Hemi ImplantAccufix Surgical, Inc. · 2020
- This deviceK240268 Accu-Joint Hemi ImplantAccufix Surgical, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K864492 | Swanson Titanium Great Toe Implant | Dow Corning Wright | 1987 | 1 |
| −10 | K971047 | Futura Biomedical Metal Hemi Toe Implant | Nexa Orthopedics, Inc. | 1997 | — |
| −9 | K031859 | Cap Great Toe Resurfacing Hemi-Arthroplasty Implant | Arthrosurface, Inc. | 2004 | — |
| −8 | K063370 | Cap 7.0MM MTP Resurfacing Hemi-Arthroplasty | Arthrosurface, Inc. | 2007 | — |
| −7 | K073065 | Osteomed Metatarsal Resurfacing Implant System | Osteomed LP | 2008 | — |
| −6 | K081876 | Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite Coating | Osteomed LP | 2008 | — |
| −5 | K102401 | Hemi Implant; Mini Hemi Implant | Vilex, Inc. | 2011 | — |
| −4 | K131377 | Hemicap MTP Resurfacing Hemi-Arthroplasty Implant | Arthrosurface, Inc. | 2013 | — |
| −3 | K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | Arthrosurface, Inc. | 2016 | — |
| −2 | K190543 | Cannulated Hemi Implant | Vilex IN Tennessee, Inc. | 2019 | — |
| −1 | K200951 | Accu-Joint Hemi Implant | Accufix Surgical, Inc. | 2020 | — |
| 0 (this device) | K240268 | Accu-Joint Hemi Implant | Accufix Surgical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 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 KWD? 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 KWD device
- #1 K250074 HYALEX® MTP Hemiarthroplasty Implantscore 13.2 · 8 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K200951 | Accu-Joint Hemi ImplantSummary page 7…K240268 Page 2 of 2 Predicate Device 510k Number Trade or Proprietary or Model Name Manufacturer K200951 Accu-Joint Hemi Implant Accufix Surgical Inc. Reference Devices 510k Number Trade or Proprietary… | 2020 |
| † | K203634 | BioPoly Great Toe Hemiarthroplasty Implant | 2021 |
| † | K222964 | BioPoly Lesser Toe Hemiarthroplasty Implant | 2022 |
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?
- The line of descent spans 37 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 28 ancestors have a recall of any class.
How does its category compare?
All KWD devicesKWD Prosthesis, Toe, Hemi-, Phalangeal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · KWD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KWD
47in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWD
10in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWD
8in 2025
MAUDE reports naming product code KWD, 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 | 5 | 65 | 0 | 0 |
| 2008 | 3 | 84 | 1 | 2 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 3 | 47 | 0 | 1 |
| 2013 | 2 | — | 0 | 4 |
| 2014 | 0 | — | 1 | 3 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 1 | — | 1 | 7 |
| 2017 | 1 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 2 | — | 0 | 19 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 2 | — | 10 | 10 |
| 2023 | 1 | — | 0 | 27 |
| 2024 | 1 | — | 0 | 133 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Accu-Joint Hemi Implant, a hemi-arthroplasty metatarsal head or phalangeal base implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock, along with the following clinical conditions: Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint. The Accu-Joint Hemi Implant is intended to be used with bone cement.
The metatarsal head and phalangeal base may not be used together at the same joint.
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/K240268 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240268: Accu-Joint Hemi Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240268
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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