STERISPINE PS KITM640Recalls & reported problems

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

Jun 3, 2022Completed
The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.
Z-1572-2022 · Root cause: Labeling Change Control · FDA record ↗

Device details

UDI-DI	`03760219910053`
Brand	STERISPINE PS
Model	KITM640
Company	Safe Orthopaedics
Product code	NKB · Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Class	Class 2
FDA submission	K112453
Implant	Yes
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 12, 2026

Device type (GMDN): Spinal bone screw, non-bioabsorbable

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Other Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease devices

EXPEDIUM VERSE 199721000
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CD HORIZON® Spinal System 8590855
Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
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Vitality® 07.02011.001
Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease
3 recalls0 reports
EXPEDIUM VERSE 199721001S
Medos International Sàrl · Thoracolumbosacral pedicle screw system
124 reports
LineSider LS-N6SA7550
Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System
2 recalls1 report
LineSider LS-N6SA6545
Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System
2 recalls0 reports
EXPEDIUM VERSE 199721000S
Medos International Sàrl · Thoracolumbosacral pedicle screw system
97 reports

All Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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