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Medartis Inc.

Last updated September 17, 2026

What Medartis Inc. makes

Medartis Inc. manufactures orthopaedic hardware including non-bioabsorbable bone screws, fixation plates, and internal fixation system kits. Their reusable devices include sterilization/disinfection containers, surgical implant templates, and positioning instruments for orthopaedic prosthesis implantation. The APTUS and Stratum Ankle systems are among the products designed for bone stabilization and joint replacement procedures.

The company’s portfolio is regulated under FDA’s UDI system, with devices classified as Class I and Class II. Products are listed in the FDA’s Unique Device Identifier database. Medartis Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: 1195 Polk Drive, Warsaw, IN, 46582
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3009540749
DUNS Number: 192756786

Catalogue (5070)

Page 100 of 102

Device	Model / Reference	Registries	Class	Status
Aptus	A-5950.22/1S	FDA UDI	Class II	Active
Aptus	A-4750.133	FDA UDI	Class II	Active
Aptus	A-4951.05	FDA UDI	Class II	Active
Aptus	A-5850.75/1	FDA UDI	Class II	Active
Aptus	A-4960.35S	FDA UDI	Class II	Active
Aptus	A-6605.001	EUDAMEDFDA UDI	Class I	Active
Stratum	STRM-LK-4028ST	FDA UDI	Class II	Unknown
Aptus	A-5786.21/1	FDA UDI	Class II	Active
Stratum Ankle	SANLS5072NS	FDA UDI	Class II	Active
InCore MPJ	IC-MPJ-0129	FDA UDI	Class I	Active
Stratum Ankle	SANLS3520S	FDA UDI	Class II	Active
MSP Metatarsal Shortening Plate Driver	MS-DR	FDA UDI	Class I	Active
Stratum Ankle	SANLS5020NS	FDA UDI	Class II	Active
Stratum	STRM-LK-3516ST	FDA UDI	Class II	Unknown
InCore Lapidus	IC-LAP-0106	FDA UDI	Class I	Active
Stratum Ankle	SANLS3576NS	FDA UDI	Class II	Active
Stratum Ankle	SACAN6060	FDA UDI	Class II	Active
Stratum Ankle	TRLTTCSTLT	FDA UDI	Class I	Active
Stratum Ankle	SALS5024S	FDA UDI	Class II	Active
InCore MPJ	IC-MPJ-2738	FDA UDI	Class II	Active
Stratum Ankle	SALS3560NS	FDA UDI	Class II	Active
Arcus Staple System	ARC-0808A	FDA UDI	Class II	Active
Calcshift Instrument System	1031-10008-3	FDA UDI	Class I	Active
Stratum Ankle	SALS5058S	FDA UDI	Class II	Active
InCore Subtalar	ICSUBPLUG	FDA UDI	Class II	Active
Stratum Ankle	SA20KWIRES	FDA UDI	Class I	Active
InCore Lapidus	IC-LAP-KW20	FDA UDI	Class I	Active
InCore Lapidus	IC-LAP-0121	FDA UDI	Class I	Active
Stratum Ankle	SACAN6075	FDA UDI	Class II	Active
Stratum Ankle	SAPTCOUTSML	FDA UDI	Class I	Active
Stratum Ankle	SALS5068S	FDA UDI	Class II	Active
Stratum	STRM-LK-2720ST	FDA UDI	Class II	Unknown
Nextra CH	CH-M425M	FDA UDI	Class II	Active
Lapiprep Lapidus Preparation System	LPFRMR	FDA UDI	Class I	Active
Stratum	STRM-DRL-35	FDA UDI	Class I	Active
Calcshift Instrument System	1031-10007	FDA UDI	Class I	Active
Stratum	STRM-DRL-20	FDA UDI	Class I	Active
InCore Subtalar	ICSUBDBL	FDA UDI	Class I	Active
Stratum Ankle	SANLS5020S	FDA UDI	Class II	Active
Stratum RS	STRM-LK-2440RS-ST	FDA UDI	Class II	Unknown
Calcshift Instrument System	1031-11005	FDA UDI	Class I	Active
InCore MPJ	IC-MPJ-2752	FDA UDI	Class II	Active
Stratum Ankle	SANLS3522S	FDA UDI	Class II	Active
Re+Line Compression Screw	RS-2714	FDA UDI	Class II	Active
InCore Lapidus	IC-LAP-T10	FDA UDI	Class I	Active
Stratum Ankle	SATHDWIRES	FDA UDI	Class I	Active
Stratum	STRM-NL-2720ST	FDA UDI	Class II	Active
Stratum Ankle	SALS3538S	FDA UDI	Class II	Active
InCore MPJ	IC-MPJ-0119	FDA UDI	Class I	Active
InCore Subtalar	ICSUBPF	FDA UDI	Class I	Active

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Medartis Inc. has two FDA recall records on file, with the earliest initiated on October 1, 2014, and the most recent on April 12, 2024. The records reflect recalls with statuses of open, classified, and terminated. One involved a product with a screw measuring 16mm instead of the specified 22mm length, while the other concerned breakage of the temporary tension bolt in the APTUS Ulna Shortening 2.5 instrument, based on three reported complaints.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Apr 12, 2024	Z-1821-2024	—	open, classified	Screw is 16mm long instead of 22mm long.
Oct 1, 2014	Z-0150-2015	—	terminated	A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt.