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

New York, NY, US

Small Bone Innovations, Inc. appears in FDA device records in New York, NY. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.

FDA records held for this company

510(k) clearances
24
PMA records
0
Recall records
3
Registered establishments
0

510(k) clearance history

FDA records hold 24 510(k) clearances for Small Bone Innovations, Inc. between 2005 and 2013. The busiest year on record is 2007, with 9. The most recent is 2013, with 1.

Clearances by year, as a table
510(k) clearance decisions for Small Bone Innovations, Inc., by decision year
YearClearances
20054
20065
20079
20081
20103
20121
20131
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K130147ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)HSBSubstantially Equivalent
K112982ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )HSBSubstantially Equivalent
K102180RHEAD RADIAL HEAD EXTENDED STEMSJDBSubstantially Equivalent
K092754SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061HWCSubstantially Equivalent
K093550MINI RAIL EXTERNAL FIXATOR SYSTEMKTTSubstantially Equivalent
K073635SBI SR MTP TOE IMPLANTKWDSubstantially Equivalent
K071541SBI TWISTOFIXHWCSubstantially Equivalent
K063635SBI FOREFOOT SETHWCSubstantially Equivalent
K071656SBI ARTFIXHWCSubstantially Equivalent
K071540SBI TITANIUM THREADED PINJDWSubstantially Equivalent
K071549SBI RHEAD PLATING SYSTEMHRSSubstantially Equivalent
K071479SBI STAFIXJDRSubstantially Equivalent
K071394MODIFICATION TO:SBI RINGFIXKTTSubstantially Equivalent
K070793SBI DISTAL RADIUS VOLAR PLATING SYSTEMHRSSubstantially Equivalent
K070236SBI LATERAL RADIO CAPITELLUMJDBSubstantially Equivalent
K062898SBI LATERAL RHEAD IMPLANTKWISubstantially Equivalent
K062903SBI CARPAL FUSION PLATEHRSSubstantially Equivalent
K062040SBI TRIHEDRON MTP HEMI GTKWDSubstantially Equivalent
K061146SBI ULNAR HEAD IMPLANTKXESubstantially Equivalent
K060038SBI RADIO-CAPITELLAR IMPLANTJDBSubstantially Equivalent
K052576SBI AUTOFIXHWCSubstantially Equivalent
K051747SBI WRISTFITHRSSubstantially Equivalent
K051605SBI K-WIRESHTYSubstantially Equivalent
K050462SBI HAND FIXATION SYSTEM (TM)HRSSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2127-2014Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotom ies geared towards a functionally stable osteosynthesis in small bones.Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments to update the IFU.Class IITerminated
Z-1720-2014SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy.Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires labeled as item #451-3004 Drill tip 1.8 mm diameter 400mm olive k-wire packaged with item #451-3005 Bayonet tip 1.8mm diameter 400mm olive k-wire inside.Class IITerminated
Z-0098-2014Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma Coated, rHead Recon Radial Stem Plasma Coated, rHead Radial Stem 6mm Collar Plasma Coated, rHead Recon Radial Stem 6mm Collar Plasma Coated, uHead Ulnar Stem Standard, uHead Ulnar Stem 20mm Collar packaged in a sterile pouch inside a shrink-wrapped box. The recall was expanded on December 20, 2013 to include the following devices: rHead lateral assembly, radial head implant, sizes 2 through 4, Uni-elbow lateral assembly, radial implant assembly, sozes 2 through 4, ReMotion Left, large distal radial component, x-small, small, medium, and large, ReMotion Right, distal radial component, x-small, small, medium, and large.The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.Class IITerminated

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