510(k) Report

510(k) · Cleared

Cleared

K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System)

K023770510(k) SpecialCleared Dec 12, 200230-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

Kinetikos Medical, Inc. · KWD Prosthesis, Toe, Hemi-, Phalangeal

Cleared on Dec 12, 2002 as substantially equivalent to K014164 (Harmos Orthopaedics, Inc., 2002) after a 30-day review. Its family tree reaches back 1 generation to 2002. 29 later devices descend from it.

Decided
Dec 12, 2002
Review
30 days
Class
Class II
Product code
KWD
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K014164 (2002). 29 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2012: 2 descendants cleared2006: 2 descendants cleared2007: 5 descendants cleared2004: 1 descendant cleared2010: 1 descendant cleared2008: 2 descendants cleared2016: 1 descendant cleared2013: 2 descendants cleared2009: 1 descendant cleared2019: 2 descendants cleared2023: 1 descendant cleared2022: 2 descendants cleared2021: 1 descendant cleared2020: 1 descendant cleared2017: 1 descendant cleared2026: 1 descendant cleared2011: 1 descendant cleared2024: 2 descendants clearedReference device: K971047 · Futura Biomedical Metal Hemi Toe Implant · Nexa Orthopedics, Inc. · 1997K014164 · Great Toe Implant System · Harmos Orthopaedics, Inc. · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 7 descendants2 generations forward: 10 descendants3 generations forward: 9 descendants4 generations forward: 3 descendants K014164 · Great Toe Implant System · Harmos Orthopaedics, Inc. · 20020
  1. Root · 1 generation backK014164 Great Toe Implant SystemHarmos Orthopaedics, Inc. · 2002
  2. This deviceK023770 K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System)Kinetikos Medical, Inc. · 2002
  3. Descendant · cites it directly · 23 of its ownK031859 Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2004
  4. Descendant · 2 generations on · 18 of its ownK070052 Met-Head Model# MHDD-XX:CC Diameter, CC CannulationVilex, Inc. · 2007
  5. Descendant · 2 generations on · 16 of its ownK063370 Cap 7.0MM MTP Resurfacing Hemi-ArthroplastyArthrosurface, Inc. · 2007
  6. Descendant · cites it directly · 16 of its ownK060536 Osteomed 1ST MPJ Hemi Implant SystemOsteomed LP · 2006
  7. Descendant · 2 generations on · 15 of its ownK073065 Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2004: 12006: 22007: 52008: 22009: 12010: 12011: 12012: 22013: 22016: 12017: 12019: 22020: 12021: 12022: 22023: 12024: 22026: 1
2004high 5 (2007) · low 0 (2005)2026

Most influential descendants

Showing 5 of 29 · See all
  • K031859Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2004 · cites it directly23descendants
  • K070052Met-Head Model# MHDD-XX:CC Diameter, CC CannulationVilex, Inc. · 2007 · 2 generations on18descendants
  • K063370Cap 7.0MM MTP Resurfacing Hemi-ArthroplastyArthrosurface, Inc. · 2007 · 2 generations on16descendants
  • K060536Osteomed 1ST MPJ Hemi Implant SystemOsteomed LP · 2006 · cites it directly16descendants
  • K073065Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008 · 2 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K014164Great Toe Implant SystemHarmos Orthopaedics, Inc.2002—
0 (this device)K023770K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System)Kinetikos Medical, Inc.2002—
+1K031859Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc.2004—
+2K070052Met-Head Model# MHDD-XX:CC Diameter, CC CannulationVilex, Inc.2007—
+2K063370Cap 7.0MM MTP Resurfacing Hemi-ArthroplastyArthrosurface, Inc.2007—
+1K060536Osteomed 1ST MPJ Hemi Implant SystemOsteomed LP2006—
+2K073065Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200620
200750
200820
200910
201010
201110
201220
201320
201610
201710
201920
202010
202110
202220
202310
202420
202610
FIG. 1 — Lineage of K023770, 2002–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K014164Great Toe Implant SystemHarmos Orthopaedics, Inc.2002—
†K971047Futura Biomedical Metal Hemi Toe ImplantNexa Orthopedics, Inc.1997—

What descends from it? (29)

See all 29

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K031859Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc.200423
K060536Osteomed 1ST MPJ Hemi Implant SystemOsteomed LP200616
K113752Metatarsal Decompression Implant Surgical Instrument SetSolana Surgical, LLC201210
K092047Ascension Metal Great Toe SystemAscension Orthopedics, Inc.20101
K062908Orthropro Hemi ToeOrthopro, LLC20061
K120029Hemi Phalangeal Implant Surgical Instrument SetSolana Surgical, LLC20120
K0729223S Hemi ToeTrilliant Surgical, Ltd.20070

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?

  • Its one ancestor has no recall.
  • Of its descendants, K031859 (Arthrosurface, Inc., 2004) has gone furthest, with 23 descendants of its own.

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?

The K2 Hemi Great Toe Implant System is 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 MTP joint.

Indications for use as stated in the FDA summary.

More from Kinetikos Medical, Inc.

19 FDA decisions under this applicant name. See the company

  • K061749Eclipse Total Ankle ImplantKinetikos Medical, Inc. · 2006
  • K061465Kmi Cement Restrictor ImplantKinetikos Medical, Inc. · 2006
  • K051611Mbaresorb ImplantKinetikos Medical, Inc. · 20053 recalls
  • K041461Kmi Distal Volar Radius Plate SystemKinetikos Medical, Inc. · 2004
  • K032806Katalyst Radial Head ImplantKinetikos Medical, Inc. · 2004

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/K023770 · printed Nov 4, 2026

Cite this page

510(k) Report. “K023770: K2 Hemi Toe Implant System (Formerly Zobel Great Toe 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/K023770

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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