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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 101 of 102

Device	Model / Reference	Registries	Class	Status
Stratum Ankle	SANLS3538NS	FDA UDI	Class II	Active
MSP Metatarsal Shortening Plate Kit	MS-SSL	FDA UDI	Class II	Active
Stratum Ankle	SANLS3572S	FDA UDI	Class II	Active
Calcshift Instrument System	1031-10015	FDA UDI	Class I	Active
Lapiprep Lapidus Preparation System	LPCGR	FDA UDI	Class I	Active
Stratum Ankle	SALS5070S	FDA UDI	Class II	Active
InCore Lapidus	IC-LAP-32R	FDA UDI	Class II	Active
Stratum Ankle	TRANTSMRT	FDA UDI	Class I	Active
InCore MPJ	IC-MPJ-4918LP	FDA UDI	Class II	Active
Stratum Ankle	SAOLIVELGS	FDA UDI	Class I	Active
Stratum Ankle	SALS5060S	FDA UDI	Class II	Active
Stratum RS	STRM-LK-2442RS-ST	FDA UDI	Class II	Unknown
InCore TMT	IC-TMT-0131	FDA UDI	Class I	Active
InCore TMT	IC-TMT-0000	FDA UDI	Class I	Active
Stratum	STRM-LK-2744ST	FDA UDI	Class II	Unknown
InCore TMT	IC-TMT-0116	FDA UDI	Class I	Active
Stratum	STRM-NL-2722ST	FDA UDI	Class II	Active
Stratum Ankle	SANLS3564S	FDA UDI	Class II	Active
InCore TMT	IC-TMT-2718	FDA UDI	Class II	Active
Stratum RS	STRM-LK-2418RS-ST	FDA UDI	Class II	Unknown
Stratum Ankle	SALS5076S	FDA UDI	Class II	Active
Stratum	STRM-MDS-3516ST	FDA UDI	Class II	Active
Stratum RS	STRM-PNUT2-RS	FDA UDI	Class II	Active
Stratum Ankle	SANLS5064NS	FDA UDI	Class II	Active
Stratum Ankle	SACUROSTLG	FDA UDI	Class I	Active
Stratum Ankle	SANLS5078S	FDA UDI	Class II	Active
InCore MPJ	IC-MPJ-0128	FDA UDI	Class I	Active
InCore TMT	IC-TMT-2734	FDA UDI	Class II	Active
InCore Subtalar	ICSUB80PDD	FDA UDI	Class I	Active
Stratum Ankle	SALS5072NS	FDA UDI	Class II	Active
Stratum Ankle	SALS3554S	FDA UDI	Class II	Active
Stratum Ankle	SANLS5024S	FDA UDI	Class II	Active
Stratum Ankle	SALS3534NS	FDA UDI	Class II	Active
Stratum	STRM-LAP-SML	FDA UDI	Class II	Active
Stratum Ankle	SANLS5044S	FDA UDI	Class II	Active
InCore MPJ	IC-MPJ-0109	FDA UDI	Class I	Active
Stratum	STRM-LK-4062ST	FDA UDI	Class II	Unknown
Stratum	STRM-PNUT2	FDA UDI	Class II	Active
Stratum Ankle	SACRSSTRAY	FDA UDI	Class II	Active
Nextra CH	CH-425M	FDA UDI	Class II	Active
Stratum	STRM-MDS-3534ST	FDA UDI	Class II	Active
Stratum RS	STRM-LK-2430RS-ST	FDA UDI	Class II	Unknown
Stratum	STRM-LK-2740ST	FDA UDI	Class II	Unknown
Stratum	STRM-1LF2	FDA UDI	Class II	Active
InCore Lapidus	IC-LAP-0001R	FDA UDI	Class II	Active
Stratum	STRM-MDS-3522ST	FDA UDI	Class II	Active
Stratum Ankle	SALS5046S	FDA UDI	Class II	Active
Stratum	STRM-NL-2712ST	FDA UDI	Class II	Unknown
Stratum	STRM-TN-SMR	FDA UDI	Class II	Active
InCore MPJ	IC-MPJ-0123	FDA UDI	Class I	Active

Related Companies

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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.