Chrysalis Intelligence · Sponsors · K2m, Inc.

K2m, Inc.

Leesburg, VA, US · 8 510(k) clearances · 35 recalls

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Total clearances
8
2020-02-07 → 2026-03-17
Last 12 months
3
Product codes
5
Most recent
2026-03-17
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OLO Orthopedic Stereotaxic Instrument Class II Neurology 3 2026-03-17
NKB Thoracolumbosacral Pedicle Screw System Class II Orthopedic 2 2026-02-10
PLR Spinal Vertebral Body Replacement Device - Cervical Class II Orthopedic 1 2022-02-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Class II Orthopedic 1 2020-02-18
NKG Posterior Cervical Screw System Class II Orthopedic 1 2020-02-07
Safety

Recalls (35)

Class I (serious)
0
Risk of injury / death
Total recalls
35
Currently ongoing
3
Most recent
2022-06-13
DateSeverityStatusRecall # ProductCodeReason
2022-06-13 Class II Ongoing Z-1307-2022 Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments. — Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may …
2022-01-13 Class II Ongoing Z-0706-2022 Everest MI XT Outer Dilator, Catalog Number 5101-90168 — Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dil…
2022-01-13 Class II Ongoing Z-0705-2022 Everest MI XT Inner Dilator, Catalog Number 5101-90167 — Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some di…
2021-09-08 Class II Terminated Z-0104-2022 Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068 — Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requi…
2021-05-07 Class II Terminated Z-1697-2021 Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are intervertebral body … — Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
2021-05-07 Class II Terminated Z-1696-2021 Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body … — Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
2021-05-07 Class II Terminated Z-1695-2021 Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar implants are intervertebral body fu… — Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
2021-03-16 Class II Terminated Z-1410-2021 Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (ce… — Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with…
2020-12-14 Class II Terminated Z-0931-2021 Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System — The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).
2020-11-04 Class II Terminated Z-0542-2021 Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT screw by rock… — All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between tool s metal shaft component and handle, resulting in leakage…
2020-11-03 Class II Terminated Z-0520-2021 Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment… — Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay…
2020-04-13 Class II Terminated Z-2031-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2030-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2029-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2028-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2027-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2026-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2025-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2024-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2023-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2022-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2021-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2020-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2019-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2018-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2017-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2016-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2015-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2014-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2013-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2012-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2011-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2010-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2009-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
2020-04-13 Class II Terminated Z-2008-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901… — The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d…
Filings

All 510(k) clearances (8)

Date K-number Device Code Class Specialty
2026-03-17 K260546 Q Pedicle Instruments OLO Class II Neurology
2026-02-10 K253545 Vulcan Spinal System NKB Class II Orthopedic
2026-02-06 K252873 Q Interbody Instruments OLO Class II Neurology
2022-02-24 K211320 CAPRI Corpectomy Cage System PLR Class II Orthopedic
2020-10-26 K202528 Cannulated Power Driver Attachment NKB Class II Orthopedic
2020-08-07 K201006 K2M Navigation Instruments OLO Class II Neurology
2020-02-18 K193203 MOJAVE Expandable Interbody System MAX Class II Orthopedic
2020-02-07 K193129 Yukon OCT Spinal System NKG Class II Orthopedic
Data source: openFDA · Generated 2026-09-07 09:19 · Last ingest 2026-09-07T13:19:27.426703 · Pipeline: Chrysalis Intelligence