IMPIX 3D Print Cages

by Medicrea International SA

510(k) K163595

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K163595↗

FDA record

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK163595	Date13 Nov 2017Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K163595

Recalls

2 recalls · 1 ongoing · FDA

- Ongoing Z-2452-2023 FDA Class II initiated 12 Jul 2023
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
- Terminated Z-1156-2020 FDA Class II initiated 2 Oct 2019
Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter

Timeline

3 dated events

13 Nov 2017 Cleared FDA 510(k) K163595
2 Oct 2019 Recall initiated FDA recalls Z-1156-2020
12 Jul 2023 Recall initiated FDA recalls Z-2452-2023

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K163595
FDA product code: MAX

Device class: Class II
Regulation: 21 CFR Part 888.3080
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Impix 3D Print Cages are intervertebral body fusion devices designed for lumbar spinal stabilization. Manufactured via additive manufacturing using titanium alloy (Ti-6Al-4V ELI), these cages are intended for use in spinal fusion procedures to provide immobilization, stabilization, and mechanical support to the anterior spinal segment, thereby facilitating vertebral fusion.

These devices are implanted by surgeons during orthopedic procedures and are supplied as single-use implants. The Impix 3D Print Cages are regulated under the FDA’s 510(k) pathway, classified under the product code MAX and reviewed by the Orthopedic (OR) Advisory Committee. No third-party review was required for this submission, and the device was determined to be substantially equivalent to the predicate.

Devices cleared under K163595

98 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K163595
		UDI-DI	Size and differences
IMPIX 3D Print A24000160 Medicrea International SA	A24000160	03613720267546	Single use: no	No longer on the market
IMPIX 3D Print A24000180 Medicrea International SA	A24000180	03613720267584	Single use: no	No longer on the market
IMPIX 3D Print A24200010 Medicrea International SA	A24200010	03613720267591	Single use: no	No longer on the market
IMPIX 3D Print A24200100 Medicrea International SA	A24200100	03613720271635	Single use: no	On the market
IMPIX 3D Print A24200200 Medicrea International SA	A24200200	03613720281627	Single use: no	On the market
IMPIX 3D Print A24200608 Medicrea International SA	A24200608	03613720267638	Single use: no	No longer on the market
IMPIX 3D Print A24200609 Medicrea International SA	A24200609	03613720267645	Single use: no	No longer on the market
IMPIX 3D Print A24200610 Medicrea International SA	A24200610	03613720267652	Single use: no	No longer on the market
IMPIX 3D Print A24200613 Medicrea International SA	A24200613	03613720267683	Single use: no	No longer on the market
IMPIX 3D Print A24200614 Medicrea International SA	A24200614	03613720267690	Single use: no	No longer on the market
IMPIX 3D Print A24600010 Medicrea International SA	A24600010	03613720267782	Single use: no	No longer on the market
IMPIX 3D Print A24600010L Medicrea International SA	A24600010L	03613720267805	Single use: no	No longer on the market
IMPIX 3D Print A24600010U Medicrea International SA	A24600010U	03613720267829	Single use: no	No longer on the market
IMPIX 3D Print A24600011 Medicrea International SA	A24600011	03613720267836	Single use: no	No longer on the market
IMPIX 3D Print A24600011R Medicrea International SA	A24600011R	03613720267867	Single use: no	No longer on the market
IMPIX 3D Print A24600013 Medicrea International SA	A24600013	03613720267898	Single use: no	No longer on the market
IMPIX 3D Print A24600030A Medicrea International SA	A24600030A	03613720267942	Single use: no	No longer on the market
IMPIX 3D Print A24600050 Medicrea International SA	A24600050	03613720267959	Single use: no	No longer on the market
IMPIX 3D Print B242C08063310 Medicrea International SA	B242C08063310	03613720270584	Single use: yes	No longer on the market
IMPIX 3D Print B242C09063310 Medicrea International SA	B242C09063310	03613720270591	Single use: yes	No longer on the market
IMPIX 3D Print B242C09123310 Medicrea International SA	B242C09123310 / B242C09123310	03613720284574	Single use: yes	No longer on the market
IMPIX 3D Print B242C10062810 Medicrea International SA	B242C10062810	03613720270522	Single use: yes	No longer on the market
IMPIX 3D Print B242C10122810 Medicrea International SA	B242C10122810 / B242C10122810	03613720284451	Single use: yes	No longer on the market
IMPIX 3D Print B242C10123310 Medicrea International SA	B242C10123310 / B242C10123310	03613720284567	Single use: yes	No longer on the market
IMPIX 3D Print B242C11122810 Medicrea International SA	B242C11122810 / B242C11122810	03613720284468	Single use: yes	No longer on the market
IMPIX 3D Print B242C12062810 Medicrea International SA	B242C12062810	03613720270546	Single use: yes	No longer on the market
IMPIX 3D Print B242C12063310 Medicrea International SA	B242C12063310	03613720270621	Single use: yes	No longer on the market
IMPIX 3D Print B242C13063310 Medicrea International SA	B242C13063310	03613720270638	Single use: yes	No longer on the market
IMPIX 3D Print B242C13122810 Medicrea International SA	B242C13122810 / B242C13122810	03613720284482	Single use: yes	No longer on the market
IMPIX 3D Print B242C13123310 Medicrea International SA	B242C13123310 / B242C13123310	03613720284536	Single use: yes	No longer on the market
IMPIX 3D Print B242C14062810 Medicrea International SA	B242C14062810	03613720270560	Single use: yes	No longer on the market
IMPIX 3D Print B242C15062810 Medicrea International SA	B242C15062810	03613720270577	Single use: yes	No longer on the market
IMPIX 3D Print B242C15123310 Medicrea International SA	B242C15123310 / B242C15123310	03613720284512	Single use: yes	No longer on the market
IMPIX 3D Print B242E08062810 Medicrea International SA	B242E08062810	03613720273127	Single use: yes	No longer on the market
IMPIX 3D Print B242E09062810 Medicrea International SA	B242E09062810	03613720273141	Single use: yes	No longer on the market
IMPIX 3D Print B242E10062810 Medicrea International SA	B242E10062810	03613720273165	Single use: yes	No longer on the market
IMPIX 3D Print B242E11062810 Medicrea International SA	B242E11062810	03613720273189	Single use: yes	No longer on the market
IMPIX 3D Print B242E13062810 Medicrea International SA	B242E13062810	03613720273226	Single use: yes	No longer on the market
IMPIX 3D Print B247C07062810 Medicrea International SA	B247C07062810	03613720272779	Single use: yes	No longer on the market
IMPIX 3D Print B247C09063210 Medicrea International SA	B247C09063210	03613720272571	Single use: yes	No longer on the market
IMPIX 3D Print B247C10062810 Medicrea International SA	B247C10062810	03613720272595	Single use: yes	No longer on the market
IMPIX 3D Print B247C10063210 Medicrea International SA	B247C10063210	03613720272601	Single use: yes	No longer on the market
IMPIX 3D Print B247C11062810 Medicrea International SA	B247C11062810	03613720272625	Single use: yes	No longer on the market
IMPIX 3D Print B247C12062810 Medicrea International SA	B247C12062810	03613720272656	Single use: yes	No longer on the market
IMPIX 3D Print B247C13062410 Medicrea International SA	B247C13062410	03613720272670	Single use: yes	No longer on the market
IMPIX 3D Print B247C13062810 Medicrea International SA	B247C13062810	03613720272687	Single use: yes	No longer on the market
IMPIX 3D Print B247C13063210 Medicrea International SA	B247C13063210	03613720272694	Single use: yes	No longer on the market
IMPIX 3D Print B247C14063210 Medicrea International SA	B247C14063210	03613720272724	Single use: yes	No longer on the market
IMPIX 3D Print B247C15062810 Medicrea International SA	B247C15062810	03613720272748	Single use: yes	No longer on the market
IMPIX 3D Print B247C15063210 Medicrea International SA	B247C15063210	03613720272755	Single use: yes	No longer on the market

Similar devices

Other devices filed under FDA product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

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See all devices from Medicrea International SA →

Regulatory status

Recalls

Timeline

Coverage

Specification

Related clearances

Cites

Cited by

Overview

Devices cleared under K163595

Similar devices

Other devices from Medicrea International SA

IB3D™ PL Spinal System B241C07062209 Open recall

Pass LP Spinal System B02211070

Pass LP B02241104

UNiD ROD B33125512-01