Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011015572

FEI Number

3011015572

Entity Name

INCIPIO DEVICES

City/State/Country

Huntington, IN, US

Establishment Address

3650 West 200 North, Huntington, IN 46750, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Incipio Devices (Owner Number: 10047511)

Owner / Operator Contact Address

3650 W 200 N, Huntington, IN 46750, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VITAL MIS NAVIGATION CANNULATED TAP 8mm VITAL MIS NAVIGATION CANNULATED TAP 9mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 8.5mm VITAL MIS NAVIGATION CANNULATED TAP 10.5mm VITAL MIS NAVIGATION CANNULATED SCREWDRIVER VITAL MIS NAVIGATION CANNULATED ILIAC TAP 7mm VITAL MIS NAVIGATION CANNULATED TAP 6.5mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 9.5mm VITAL MIS NAVIGATION CANNULATED TAP 9.5mm VITAL MIS NAVIGATION CANNULATED TAP 8.5mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 9mm VITAL MIS NAVIGATION CANNULATED TAP 5mm VITAL MIS NAVIGATION STRAIGHT THORACIC PROBE VITAL MIS NAVIGATION CANN SCREWDRIVER, SHORT VITAL MIS NAVIGATION STRAIGHT LUMBAR PROBE VITAL MIS NAVIGATION CANNULATED ILIAC TAP 7.5mm VITAL MIS NAVIGATION CANNULATED TAP 10mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 6.5mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 6mm VITAL MIS NAVIGATION CANNULATED TAP 4mm VITAL NAVIGATION CANNULATED REDUCTION DRIVER VITAL MIS NAVIGATION CANNULATED ILIAC TAP 10.5mm VITAL MIS NAVIGATION AWL VITAL MIS NAVIGATION CANNULATED TAP 7.5mm VITAL MIS NAVIGATION CANNULATED TAP 6mm VITAL MIS NAVIGATION CANNULATED TAP 7mm VITAL MIS NAVIGATION CANNULATED TAP 4.5mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 8mm VITAL MIS NAVIGATION CANNULATED TAP 5.5mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 10mm Persona Partial Knee Instruments 5901-6060 - ReUnion TSA - Single Handle Cannulated Centering Guide Reamer System ZimmerBiomet SEGMENTAL PROXIMAL FEMUR TEMPLATE Persona Revision Counter-Torque Wrench PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER VITAL MIS NAVIGATION STRAIGHT LUMBAR PROBE VITAL MIS NAVIGATION STRAIGHT THORACIC PROBE PSN REV FEM SZ/CT GD SPC 10MM PSN REV TIB OFF STM ADP 3/6 MM PSN REV FEM DIST CUT GDE STEM EXTRACTOR PSN REV ROTATION ASSESSMNT GDE PSN REV ALGN ROD ADPT PSN REV TIB STR STM ADPT PSN REV FEM VAL ALGN GDE 6 DEG PSN REV FEM STEM PRV ADPT PSN REV FEM SZ/CT GD SPC 15 MM PSN REV FEM STR ADPT PSN REV FEM DRL GDE 19.5MM PSN REV FEM OFST ADPT 3/6 MM IM TIB RESECTION CUT GUIDE RT PSN REV FEM SZ/CTGD SPC 5 MM PSN REV TIB AUG CUT GDE LT PSN REV EXT TAPER IMPT PSN REV FEM ROT ALGN GDE IM TIB RESECTION BOOM 0 DEG IM TIB RESECTION CUT GUIDE LT PSN REV TIB AUG CUT GDE RT PSN REV TIB DRL GDE 19.5MM PSN REV CNTR-TRQ WRENCH ZimmerBiomet Persona Partial Knee Instruments ZimmerBiomet Template Stryker THK Reamer System ZimmerBiomet VITAL MIS NAVIGATION CANNULATED SCREWDRIVER VITAL MIS NAVIGATION CANN SCREWDRIVER, SHORT Conversion Instruments Guide, Surgical, Instrument ZimmerBiomet Zimmer Persona Personalized Knee System PG HL DRILL GDE HANDLE ASSY FEMORAL PROVISIONAL INSERTER Continuum Trilogy IT Acetabular Systems Trident Rio Straight Shell Impactor Trident Rio Inline-Offset Shell Impactor VITAL MIS NAVIGATION CANNULATED ILIAC TAP 6.5mm VITAL MIS NAVIGATION CANNULATED TAP 7.5mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 7.5mm VITAL MIS NAVIGATION CANNULATED TAP 7mm VITAL MIS NAVIGATION CANNULATED TAP 5.5mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 8.5mm VITAL MIS NAVIGATION CANNULATED TAP 4mm VITAL MIS NAVIGATION CANNULATED TAP 10.5mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 9.5mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 10mm VITAL MIS NAVIGATION CANNULATED TAP 9mm VITAL MIS NAVIGATION CANNULATED TAP 6mm VITAL MIS NAVIGATION CANNULATED TAP 8mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 7mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 8mm VITAL MIS NAVIGATION CANNULATED TAP 5mm VITAL MIS NAVIGATION CANNULATED TAP 10mm VITAL MIS NAVIGATION CANNULATED TAP 4.5mm VITAL MIS NAVIGATION CANNULATED TAP 9.5mm VITAL MIS NAVIGATION CANNULATED TAP 8.5mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 6mm VITAL MIS NAVIGATION CANNULATED TAP 6.5mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 10.5mm VITAL MIS NAVIGATION CANNULATED ILIAC TAP 9mm ZimmerBiomet Comprehensive SRS - Nexel Persona Revision epicondylar alignment guide Persona Revision femoral sizing/cut guide spacer 15 mm Persona Revision femoral offset stem reamer adapter 3/6 mm Persona Revision femoral straight stem reamer adapter Persona Revision femoral distal cut guide Persona Revision femoral sizing/cut guide spacer 5 mm Persona Revision IM tibial resection cut guide LH Persona Revision tibial augment cut guide RH Persona Revision tibial augment cut guide LH Persona Revision femoral drill guide 19.5 mm Persona Revision Knee System Persona Revision tibial straight stem reamer adapter Persona Revision IM tibial resection cut guide RH Persona Revision tibial drill guide 19.5 mm Persona Revision tibial offset stem reamer adapter 3/6 mm Persona Revision femoral sizing/cut guide spacer 10 mm Persona Revision femoral valgus alignment guide 6 deg Persona Revision IM tibial resection boom 0 deg Continuum Trilogy IT Acetabular Systems SEG PROX TIB TISSUE ATTACH KIT PROXIMAL FEMUR TEMPLATE 38MM PROXIMAL FEMUR TEMPLATE 46MM SEG TIB TISSUE ATTACH PROV LEFT SEG TIB TISSUE ATTACH PROV RIGHT PERSONA - ROSA Partial Knee System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-12-17
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-12-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-12-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-12-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-12-17
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2019-09-27
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-06-25
HTO	Reamer	Orthopedic	Class 1	888.4540	2015-06-03
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2017-11-20
HXC	Wrench	Orthopedic	Class 1	888.4540	2019-12-11
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2023-01-26
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2017-11-20
HXB	Probe	Orthopedic	Class 1	888.4540	2019-10-07
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2019-07-01
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2019-07-01
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2019-07-01
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2025-05-16
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2025-05-16
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2025-05-16
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2025-05-16
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2025-05-16
HWT	Template	Orthopedic	Class 1	888.4800	2016-02-08
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2014-09-26
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2016-02-08
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2022-01-05
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-04-25
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2021-08-04
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2021-08-04
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2017-11-20
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-06-13
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2022-06-13
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2022-06-13
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-02-18
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2019-10-07
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2024-12-12
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2020-01-07
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-01-07
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2020-01-07
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2020-01-07
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2019-12-11
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2019-12-11
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2019-12-11
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2022-06-13
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-06-13
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2022-06-13
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2017-11-20
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-01-07

Official Correspondent

Troy Johnson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Incipio Devices

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26
K010427	Walter Lorenz Surgical, Inc.	LORENZ FIDUCAIL SCREW	2001-03-15
K812744	Progress Mankind Technology	LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER	1981-12-03
K092467	Brainlab AG	VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED	2010-05-06
K031454	Biomet, Inc.	ACUMEN SURGICAL NAVIGATION SYSTEM	2004-07-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0001-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.

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3014725904	Medtronic Medical Costa Rica S.R.L.	Coyol Alajuela, CR
3018405359	A7 INTEGRATION	Granby Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011015572. Last updated year: 2026. Please use registration number 3011015572 when referencing this establishment in official correspondence.