510(k) Report

510(k) · Cleared

Cleared

Osteomed 1ST MPJ Hemi Implant System

K060536510(k) TraditionalCleared Jun 2, 200694-day reviewClass II21 CFR 888.3730

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Osteomed LP · KWD Prosthesis, Toe, Hemi-, Phalangeal

Cleared on Jun 2, 2006 as substantially equivalent to K041595 (Biopro, Inc., 2004) and 2 other predicates after a 94-day review. Its family tree reaches back 2 generations to 1987. 16 later devices descend from it.

Decided
Jun 2, 2006
Review
94 days
Class
Class II
Product code
KWD
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K864492 (1987). 5 ancestors in all. 16 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2002: 2 other ancestors2008: 2 descendants cleared2012: 1 descendant cleared2013: 2 descendants cleared2011: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared2019: 2 descendants cleared2016: 1 descendant cleared2026: 1 descendant cleared2022: 1 descendant cleared2021: 1 descendant cleared2024: 2 descendants clearedK864492 · Swanson Titanium Great Toe Implant · Dow Corning Wright · 1987 · recalledK971047 · Futura Biomedical Metal Hemi Toe Implant · Nexa Orthopedics, Inc. · 19971990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 5 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant K971047 · Futura Biomedical Metal Hemi Toe Implant · Nexa Orthopedics, Inc. · 1997K864492 · Swanson Titanium Great Toe Implant · Dow Corning Wright · 1987 · recalled0+5
  1. Root · 2 generations backK864492 Swanson Titanium Great Toe ImplantDow Corning Wright · 1987 · Recalled
  2. 1 generation backK971047 Futura Biomedical Metal Hemi Toe ImplantNexa Orthopedics, Inc. · 1997
  3. This deviceK060536 Osteomed 1ST MPJ Hemi Implant SystemOsteomed LP · 2006
  4. Descendant · cites it directly · 15 of its ownK073065 Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008
  5. Descendant · 2 generations on · 13 of its ownK081876 Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP · 2008
  6. Descendant · 3 generations on · 11 of its ownK102401 Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011
  7. Descendant · 2 generations on · 10 of its ownK113752 Metatarsal Decompression Implant Surgical Instrument SetSolana Surgical, LLC · 2012
  8. Descendant · 3 generations on · 9 of its ownK131377 Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2013

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2008: 22011: 12012: 12013: 22016: 12017: 12019: 22020: 12021: 12022: 12024: 22026: 1
2008high 2 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 16 · See all
  • K073065Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008 · cites it directly15descendants
  • K081876Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP · 2008 · 2 generations on13descendants
  • K102401Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011 · 3 generations on11descendants
  • K113752Metatarsal Decompression Implant Surgical Instrument SetSolana Surgical, LLC · 2012 · 2 generations on10descendants
  • K131377Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2013 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K864492Swanson Titanium Great Toe ImplantDow Corning Wright19871
−1K971047Futura Biomedical Metal Hemi Toe ImplantNexa Orthopedics, Inc.1997—
0 (this device)K060536Osteomed 1ST MPJ Hemi Implant SystemOsteomed LP2006—
+1K073065Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP2008—
+2K081876Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP2008—
+3K102401Hemi Implant; Mini Hemi ImplantVilex, Inc.2011—
+2K113752Metatarsal Decompression Implant Surgical Instrument SetSolana Surgical, LLC2012—
+3K131377Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200220
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
201110
201210
201320
201610
201710
201920
202010
202110
202210
202420
202610
FIG. 1 — Lineage of K060536, 1987–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K250074 HYALEX® MTP Hemiarthroplasty Implantscore 13.2 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K041595Toe MP Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870
Summary page 1
…Equivalence for this device is based on similarities in intended use, material, design and operational principle to the BioPro Hemi MP Joint (K041595), the Kinetikos Medical, K2 Hemi Toe Implant System (K023770) and the Futura BioMedical Metal…
Biopro, Inc.200410
*K023770K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System)
Summary page 1
…material, design and operational principle to the BioPro Hemi MP Joint (K041595), the Kinetikos Medical, K2 Hemi Toe Implant System (K023770) and the Futura BioMedical Metal Hemi Toe Implant (K971047). Due to the similarity of materia…
Kinetikos Medical, Inc.2002—
*K971047Futura Biomedical Metal Hemi Toe Implant
Summary page 1
…emi MP Joint (K041595), the Kinetikos Medical, K2 Hemi Toe Implant System (K023770) and the Futura BioMedical Metal Hemi Toe Implant (K971047). Due to the similarity of materials and design to the predicate devices, OsteoMed believes t…
Nexa Orthopedics, Inc.1997—

Also cleared against K041595: 6 other devices →

What descends from it? (16)

See all 16

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K073065Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP200815

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 19 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
  • 2 of the 5 ancestors have a recall of any class.
  • Of its descendants, K073065 (Osteomed LP, 2008) has gone furthest, with 15 descendants of its own.
  • 6 other devices also cite its predicate K041595.

How does its category compare?

All KWD devices

KWD Prosthesis, Toe, Hemi-, Phalangeal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWD

1in 2024

2007: 52008: 32009: 22010: 12011: 12012: 32013: 22016: 12017: 12019: 22020: 12021: 12022: 22023: 12024: 12026 (partial year): 1
2007high 5 (2007) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWD

47in 2012

2007: 65 days median2008: 84 days median2012: 47 days median
2007high 84 (2008) · low 47 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWD

10in 2022

2008: 12014: 12016: 12022: 102026 (partial year): 1
2007high 10 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWD

8in 2025

2008: 22010: 32011: 32012: 12013: 42014: 32015: 102016: 72017: 102018: 82019: 192020: 42021: 22022: 102023: 272024: 1332025: 8
2007high 133 (2024) · low 0 (2007)2025

MAUDE reports naming product code KWD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200756500
200838412
20092—00
20101—03
20111—03
201234701
20132—04
20140—13
20150—010
20161—17
20171—010
20180—08
20192—019
20201—04
20211—02
20222—1010
20231—027
20241—0133
20250—08
20261—1—

What is it indicated for?

Indicated for use in the treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions: hallux valgus, hallux rigidus and an unstable or painful metatarsophalangeal joint. OsteoMed 1st MPJ Hemi Implants are intended for single use only.

Indications for use as stated in the FDA summary.

Also cleared against K041595

6 other devices cite the same predicate.

  • K182704WishBone Guided Growth SystemWishbone Medical · 20191 recall
  • K121973Biopro Hemi-Edge Toe SystemBiopro, Inc. · 2012
  • K102401Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011
  • K083469Metasurg Cannulated Tiatanium Hemi Implant, Model HM-1000Metasurg · 2009
  • K073065Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008
  • K063058Arthrex Anatoemic Phalangeal ProsthesisArthrex, Inc. · 2007

More from Osteomed LP

29 FDA decisions under this applicant name. See the company

  • K143338Argulated Locking PlatesOsteomed LP · 2015
  • K133691Extrimilock Ankle Plating SystemOsteomed LP · 2014
  • K131445Osteomed Extremilock Foot Plating SystemOsteomed LP · 2013
  • K123885Osteomed Smartflex Cranial Spring DistractorOsteomed LP · 2013
  • K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP · 2012

Recent decisions in KWD

The KWD category page

  • K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc. · 2026
  • K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc. · 2024
  • K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity Medical · 2023
  • K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC · 2022
  • K201393restor3d MTP ImplantRestor3D, Inc. · 20221 recall

https://510kreport.com/device/K060536 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060536: Osteomed 1ST MPJ Hemi Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060536

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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