510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Wishbone Medical, Inc.

Larwill, IN, US

WISHBONE MEDICAL INC. appears in FDA device records in Larwill, IN. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
9
PMA records
0
Recall records
3
Registered establishments
1

510(k) clearance history

FDA records hold 9 510(k) clearances for Wishbone Medical, Inc. between 2017 and 2023. The busiest year on record is 2020, with 2. The most recent is 2023, with 2.

Clearances by year, as a table
510(k) clearance decisions for Wishbone Medical, Inc., by decision year
YearClearances
20171
20181
20191
20202
20222
20232
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K231461Smart Correction System (HA Half Pins)KTTSubstantially Equivalent
K230527WishBone Medical Plate and Screw SystemHRSSubstantially Equivalent
K221366Smart Correction System Rings and Compatible HA-Coated Half PinsKTTSubstantially Equivalent
K213489Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula PlateHRSSubstantially Equivalent
K203467WishBone Medical Plate and Screw SystemHWCSubstantially Equivalent
K193368Smart Correction SystemKTTSubstantially Equivalent
K182704WishBone Guided Growth SystemOBTSubstantially Equivalent
K180736WishBone Medical Plate and Screw SystemHRSSubstantially Equivalent
K173013WishBone K-Wire SystemHTYSubstantially Equivalent

Registered establishments

FDA registered establishments for Wishbone Medical, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30136801403013680140WISHBONE MEDICAL INC.1560 N State Road 5, Larwill, IN 46764 US2026and 2 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1808-2024WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated.Class IIOpen, Classified
Z-1102-2023WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to the collar release pin backing out. This may lead to a delay in correction.Class IIOpen, Classified
Z-1794-2021WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, PK-SMC0835NSR-TI-USNonconformities were discovered to the engineering specifications for implant plates and screws.Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain