510(k) · Cleared
ClearedOsteomed Metatarsal Resurfacing Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed LP · KWD Prosthesis, Toe, Hemi-, Phalangeal
Cleared on Feb 21, 2008 as substantially equivalent to K031859 (Arthrosurface, Inc., 2004) and 5 other predicates after a 114-day review. Its family tree reaches back 4 generations to 1987. 15 later devices descend from it.
- Decided
- Feb 21, 2008
- Review
- 114 days
- Class
- Class II
- Product code
- KWD
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K864492 (1987). 13 ancestors in all, the oldest K781870 (1979). 15 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK864492 Swanson Titanium Great Toe ImplantDow Corning Wright · 1987 · Recalled
- 3 generations backK971047 Futura Biomedical Metal Hemi Toe ImplantNexa Orthopedics, Inc. · 1997
- 2 generations backK031859 Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2004
- 1 generation backK063370 Cap 7.0MM MTP Resurfacing Hemi-ArthroplastyArthrosurface, Inc. · 2007
- This deviceK073065 Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008
- Descendant · cites it directly · 13 of its ownK081876 Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP · 2008
- Descendant · 2 generations on · 11 of its ownK102401 Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011
- Descendant · cites it directly · 10 of its ownK113752 Metatarsal Decompression Implant Surgical Instrument SetSolana Surgical, LLC · 2012
- Descendant · 2 generations on · 9 of its ownK131377 Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2013
- Descendant · 3 generations on · 6 of its ownK152454 HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. · 2016
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K081876Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP · 2008 · cites it directly13descendants
- K102401Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011 · 2 generations on11descendants
- K113752Metatarsal Decompression Implant Surgical Instrument SetSolana Surgical, LLC · 2012 · cites it directly10descendants
- K131377Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2013 · 2 generations on9descendants
- K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. · 2016 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864492 | Swanson Titanium Great Toe Implant | Dow Corning Wright | 1987 | 1 |
| −3 | K971047 | Futura Biomedical Metal Hemi Toe Implant | Nexa Orthopedics, Inc. | 1997 | — |
| −2 | K031859 | Cap Great Toe Resurfacing Hemi-Arthroplasty Implant | Arthrosurface, Inc. | 2004 | — |
| −1 | K063370 | Cap 7.0MM MTP Resurfacing Hemi-Arthroplasty | Arthrosurface, Inc. | 2007 | — |
| 0 (this device) | K073065 | Osteomed Metatarsal Resurfacing Implant System | Osteomed LP | 2008 | — |
| +1 | K081876 | Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite Coating | Osteomed LP | 2008 | — |
| +2 | K102401 | Hemi Implant; Mini Hemi Implant | Vilex, Inc. | 2011 | — |
| +1 | K113752 | Metatarsal Decompression Implant Surgical Instrument Set | Solana Surgical, LLC | 2012 | — |
| +2 | K131377 | Hemicap MTP Resurfacing Hemi-Arthroplasty Implant | Arthrosurface, Inc. | 2013 | — |
| +3 | K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | Arthrosurface, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (6)
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 |
|---|---|---|---|
| * | K031859 | Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantSummary page 1…materials, design and operational principle to the Arthrosurface CAP Great Toe Resurfacing Hemi- Arthroplasty Implant (K031859) and CAP Prosthetic 7.0mm MTP Resurfacing Hemi- arthroplasty (K063370),… | 2004 |
| * | K063370 | Cap 7.0MM MTP Resurfacing Hemi-ArthroplastySummary page 1…Great Toe Resurfacing Hemi- Arthroplasty Implant (K031859) and CAP Prosthetic 7.0mm MTP Resurfacing Hemi- arthroplasty (K063370), Vilex Met-Head Resurfacing Hemi- Arthroplasty Implant (K070052), Oste… | 2007 |
| * | K070052 | Met-Head Model# MHDD-XX:CC Diameter, CC CannulationSummary page 1…Prosthetic 7.0mm MTP Resurfacing Hemi- arthroplasty (K063370), Vilex Met-Head Resurfacing Hemi- Arthroplasty Implant (K070052), OsteoMed 1 st MPJ Hemi Implant System (K060536) and ReFlexion Great T… | 2007 |
| * | K060536 | Osteomed 1ST MPJ Hemi Implant SystemSummary page 1…63370), Vilex Met-Head Resurfacing Hemi- Arthroplasty Implant (K070052), OsteoMed 1 st MPJ Hemi Implant System (K060536) and ReFlexion Great Toe System (K92221 1), and BioPro Hemi MPJoint (K041595).… | 2006 |
| * | K922211 | Osteomed Great Toe SystemSummary page 1…Arthroplasty Implant (K070052), OsteoMed 1 st MPJ Hemi Implant System (K060536) and ReFlexion Great Toe System (K92221 1), and BioPro Hemi MPJoint (K041595). OsteoMed L.P. 3885 Arapaho Road Addison,… | 1993 |
| * | K041595 | Toe MP Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870Summary page 1…OsteoMed 1 st MPJ Hemi Implant System (K060536) and ReFlexion Great Toe System (K92221 1), and BioPro Hemi MPJoint (K041595). OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (9… | 2004 |
What descends from it? (15)
See all 153 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K081876 (Osteomed LP, 2008) has gone furthest, with 13 descendants of its own.
- 8 other devices also cite its predicate K031859.
How does its category compare?
All KWD devicesKWD Prosthesis, Toe, Hemi-, Phalangeal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 OsteoMed Metatarsal Resurfacing Implant, a hemi-arthroplasty 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 and integrity of the phalangeal base, along with the following clinical conditions; hallux limitus, hallux valgus, hallux rigidus, and an unstable or painful MTP joint.
The OsteoMed Metatarsal Resurfacing Implant is intended to be used with bone cement or press fit without bone cement.
The OsteoMed Metatarsal Resurfacing Implant is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073065 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073065: Osteomed Metatarsal Resurfacing Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073065
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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