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510(k) Data Aggregation
K Number
K251436Device Name
Resolve Anterior Cervical Plate System
Manufacturer
Pioneer Surgical Technology, Inc
Date Cleared
2025-07-11
(64 days)
Product Code
KWQ
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
Pioneer Surgical Technology, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K230993Device Name
CODA Anterior Cervical Plate System
Manufacturer
Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
Date Cleared
2023-06-20
(75 days)
Product Code
KWQ
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
Pioneer Surgical Technology, Inc D
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CODA™ Anterior Cervical Plate System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. Specific indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Device Description
The CODA™ Anterior Cervical Plate (ACP) System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. The system consists of non-sterile and sterile, single use plates and screws that are manufactured from titanium alloy (Ti-6Al-4V ELI). The plates have an integrated active locking mechanism, are offered in various lengths, and accommodate constrained and variable screws. The system includes non-sterile, reusable instruments and sterile, single use instruments designed to facilitate proper implantation of the plate and screws.
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K Number
K222493Device Name
CODA Anterior Cervical Plate System
Manufacturer
Pioneer Surgical Technology, Inc.,
Date Cleared
2022-11-18
(92 days)
Product Code
KWQ, KWO
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
Pioneer Surgical Technology, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CODA Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion is skeletally mature patients. Specific indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Device Description
The CODA™ Anterior Cervical Plate (ACP) System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. The system consists of non-sterile plates and screws that are manufactured from titanium alloy (Ti-6Al-4V ELI). The plates have an integrated active locking mechanism, are offered in various lengths, and accommodate constrained and variable screws. The system includes nonsterile, reusable instruments and sterile, single use instruments designed to facilitate proper implantation of the plate and screws.
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K Number
K220244Device Name
DVR® Crosslock Wrist Spanning Plate (131849181)
Manufacturer
Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
Date Cleared
2022-04-28
(90 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Pioneer Surgical Technology, Inc D
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DVR® Crosslock Wrist Spanning Plate is indicated for skeletally mature patients for fixation of fractures, osteotomies and non-unions of the distal radius.
Device Description
The DVR® Crosslock Wrist Spanning Plate is a single-use plate for the fixation of fractures, osteotomies and non-unions of the distal radius. The plate spans the patient's wrist and is placed from the radial shaft to the second or third metacture pattern and patient anatomy. The plate provides ligamentotaxis on a temporary basis while the distal radius heals. The DVR® Crosslock Wrist Spanning Plate consists of a single, sterile-packed plate and is manufactured from titanium alloy (Ti-6AL-4V). The plate features hole clusters consisting of locking screw holes, a central screw cluster, and K-wire holes for preliminary fixation. There is a dorsal bend at the distal end of the plate to accommodate patient anatomy.
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K Number
K211408Device Name
CervAlign® Anterior Cervical Plate System
Manufacturer
Pioneer Surgical Technology, Inc.
Date Cleared
2021-06-23
(48 days)
Product Code
KWQ, KWO
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
Pioneer Surgical Technology, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CervAlign Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.
Device Description
The CervAlign Anterior Cervical Plate System is designed to promote cervical fusion by providing temporary resistance to flexion, extension, lateral bending, and axial rotation with strength and stiffness in the cervical spine (C2-C7). The system includes implants of various sizes of screws and plates to accommodate varying patient anatomies. The plates have integrated cover-style locking mechanisms that actuate to cover each screw. Implants are manufactured from titanium alloy, Ti-6Al-4V ELI (ASTM F136). The implants are supplied with instrumentation necessary to facilitate the insertion and removal. The implants and instruments are provided non-sterile and must be sterilized before use. Sterilization cases and trays are provided to facilitate proper sterilization and storage.
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K Number
K201497Device Name
EVOS Cabling System
Manufacturer
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
Date Cleared
2020-10-28
(145 days)
Product Code
JDQ
Regulation Number
888.3010Why did this record match?
Applicant Name (Manufacturer) :
Pioneer Surgical Technology, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EVOS Cabling System is intended to be used in general orthopaedic repair procedures including patellar fractures, general cerclage, trochanteric reattachment, femoral and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nail and screw fixation techniques.
Device Description
The EVOS Cabling System is used in orthopedic trauma and reconstructive surgeries to reduce and stabilize fractures and osteotomies. The EVOS Cabling System may be used for supplementary fracture fixation when used with bone plates or screws. The EVOS Cabling System includes a sterile, stainless-steel cable implant (ASTM F1314) packaged together with a stainless-steel crimp (ASTM F138). Non-sterile, reusable instruments are also provided to facilitate proper implantation of the cable-crimp implant.
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K Number
K200513Device Name
DAC Dynamic Active Compression Plate
Manufacturer
Pioneer Surgical Technology, Inc., DBA RTI Surgical
Date Cleared
2020-07-22
(142 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Pioneer Surgical Technology, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DAC plate system with proprietary compression technology is indicated for use in skeletally mature patients for stabilization and fixation of fractures, revisions, arthrodeses and reconstruction of small bones of the foot such as:
- Midfoot and hindfoot arthrodeses or osteotomies
- Tarsometatarsal arthrodeses (metatarsocuneiform, metatarsocuboid, Lapidus)
- Intercuneiform arthrodeses
- Naviculocuneiform arthrodeses
- Talonavicular arthrodeses
- Calcaneocuboid arthrodeses
- Linsfranc arthrodeses
- Mono-or-bi-cortical osteotomies in the forefoot, midfoot and hindfoot
- First metatarsophalangeal arthrodeses
Device Description
The DAC Dynamic Active Compression Plate (DAC plate) System is a zero-step locking plate that provides stability and active compression. The system includes screws and plates of varying sizes and configurations to accommodate various patient anatomies. The plates contain nitinol wires housed under tension in sliders kept in place with release pins. When the built-in release pins are removed, the nitinol wires return to their straight condition, creating compression. The implant components of the system are manufactured from titanium alloy (ASTM F136) and nitinol (ASTM F2063). The components of this system should not be used with components of any other system. The implants are provided non-sterile and are supplied with instrumentation to facilitate use of the device components.
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K Number
K200095Device Name
Streamline Navigated Instruments
Manufacturer
Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc.
Date Cleared
2020-06-26
(162 days)
Product Code
OLO
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Pioneer Surgical Technology, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Streamline Navigated Instruments are intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT- or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
Device Description
The Streamline Navigated Instruments are non-sterile, reusable instruments for use with the Medtronic StealthStation Navigation System to assist surgeons in precisely locating anatomical structures in either open or minimally invasive (MIS) procedures for preparation and placement of screws from the Streamline TL Spinal Fixation System and Streamline MIS Spinal Fixation System and preparation of screws from the Streamline OCT Occipito-Cervico-Thoracic System. The Streamline Navigated Instruments include pedicle finders, modular handle, taps, drills, and screw inserters designed for use with Streamline TL, Streamline MIS, and Streamline OCT Systems. The instruments are manufactured from stainless steel (ASTM F899).
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K Number
K193468Device Name
Tritium Sternal Cable Plate System
Manufacturer
Pioneer Surgical Technology, Inc. (dba RTI Surgical, Inc.)
Date Cleared
2020-03-12
(87 days)
Product Code
JDQ, HRS, HWC
Regulation Number
888.3010Why did this record match?
Applicant Name (Manufacturer) :
Pioneer Surgical Technology, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tritium® Sternal Cable Plate System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.
Device Description
The Tritium® Sternal Cable Plate System includes implants of various sizes; plates and cable plugs comprised of commercially pure titanium, Grade IV (ASTM F67), and cables and screws comprised of Titanium 6AI 4V Alloy (ASTM F136). The system also includes needles comprised of Custom 470 stainless steel, 420 stainless steel (ASTM F899, Custom 470 SST) and leader comprised of Titanium 3AI/ 2.5V Alloy (ASTM F2146).
The system is designed to enhance the stability and strength of traditional sternal closure techniques. Utilizing a unique load sharing concept, the device can be implanted to distribute lateral force across the osteotomy. The system can be used with traditional monofilament wire or Pioneer Sternal Cable. The device system should be implanted using only the manual surgical instruments designed specifically for this system of implants, which may be implanted via an open or minimally invasive approach.
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K Number
K192800Device Name
Streamline TL Spinal Fixation System
Manufacturer
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
Date Cleared
2020-01-14
(106 days)
Product Code
NKB, KWP
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Pioneer Surgical Technology, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Streamline TL Spinal Fixation System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (T1-S2), posterior hook (T1-L5) or sacral/iliac screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudarthrosis, and failed previous fusion.
Device Description
The Streamline TL Spinal System consists of a variety of rods, screws (poly-axial, fixed, and reduction), rod connectors, crosslinks, set screws, hooks and other connecting components used to build a spinal construct. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The Streamline TL Spinal System includes Class I manual instrumentation to facilitate implantation of the device components.
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