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Paragon 28

Last updated September 17, 2026

Information

Country: US
Address: 14445 Grasslands Dr., Englewood, CO, 80112
Website: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3008650117
DUNS Number: —

Catalogue (5858)

Page 116 of 118

Device	Model / Reference	Registries	Class	Status
Multi System	P99-192-2015	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-810-TUA3	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-181-BL1S-S	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-180-BR4S-S	FDA UDI	Class II	Active
Multi System	P99-292-1115	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-130-0026	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-854-RAD1	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-180-BR5L-S	FDA UDI	Class II	Active
Dynamic Syndesmosis	P80-142-1457-S	FDA UDI	Class II	Active
Lesser Metatarsal Shortening System	P35-911-1000	FDA UDI	Class I	Active
Precision MIS Bunion System	P27-101-100R	FDA UDI	Class I	Active
Precision MIS Bunion System	P27-135-0058	FDA UDI	Class II	Active
Dynamic Syndesmosis	P80-142-1452-S	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-193-OR10	FDA UDI	Class I	Active
Precision MIS Bunion System	P27-931-35MD	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-851-P051	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-135-0024	FDA UDI	Class II	Active
Special Instrument	SP31-950-0006	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-180-BR3L-S	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AONLS3012	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-140-0044	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-130-0040	FDA UDI	Class II	Active
Multi System	P99-190-TX06	FDA UDI	Class II	Active
Multi System	PCT-005	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-851-P021	FDA UDI	Class I	Active
Paragon 28 Bone Wedge System	AOCW-16-8	FDA UDI	Class II	Active
Multi System	P99-150-1243	FDA UDI	Class I	Active
Lesser Metatarsal Shortening System	P35-940-0225	FDA UDI	Class I	Active
Paragon 28 Bone Wedge System	AONLS3024	FDA UDI	Class II	Active
Multi System	P99-150-1343	FDA UDI	Class I	Active
Precision MIS Bunion System	P27-135-0038	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AONLS3016	FDA UDI	Class II	Active
FJ2000 System	P65-001-0006-SK	FDA UDI	Class I	Active
Paragon 28 Bone Wedge System	AOEW-18-10	FDA UDI	Class II	Active
Bun-Yo-Matic™ Lapidus Clamp System	P30-960-1201R	FDA UDI	Class I	Active
MAVEN™ Patient-Specific Instrumentation	P11-PSI-L105	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-210-555S	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-410-0300	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AONLS3026	FDA UDI	Class II	Active
Dynamic Syndesmosis	P80-142-1752-S	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOCWO-20-6	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-181-BR1S-S	FDA UDI	Class II	Active
Dynamic Syndesmosis	P80-142-1450-S	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-193-3023	FDA UDI	Class I	Active
Paragon 28 Bone Wedge System	AOCW-18-10 TRL	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-810-TUF4	FDA UDI	Class II	Active
FJ2000 System	P65-108-2913-S	FDA UDI	Class I	Active
Paragon 28 Bone Wedge System	AOCW-TRL-18-5.5	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOCWO-20-8 TRL	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOCWO-16-5	FDA UDI	Class II	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.

Date	Recall No.	Class	Status	Reason
Sep 28, 2018	Z-0662-2020	—	terminated	It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of the product could result in improper preparation of the surgical site causing delays in surgery.
Dec 19, 2017	Z-2261-2018	—	terminated	Missing drill guide as stated in the package.