(81 days)
Not Found
Not Found
No
The device description focuses on the physical components and materials of external fixation devices and their reprocessing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes.
The device is used for "treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery," which constitutes a therapeutic use.
No
The device is an external fixation system used for the treatment and stabilization of bone conditions like fractures and osteotomies. It is a therapeutic device, not one that diagnoses a condition.
No
The device description details physical components made of materials like aluminum and stainless steel, which are hardware. The reprocessing involves cleaning, inspection, and testing of these physical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of bone conditions through external skeletal traction or fixation. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device components are physical elements (rods, rails, clamps, rings) used to create a structure for stabilizing bone. They are not used to examine specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide information about a person's health.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (within the body) for treatment.
N/A
Intended Use / Indications for Use
Reprocessed External Fixation Devices are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.
Product codes (comma separated list FDA assigned to the subject device)
KTT, LXT
Device Description
Vanguard Reprocessed External Fixation Devices are previously used non-Device invasive orthopedic devices that have been cleaned, inspected, tested, and Description packaged by Vanguard Medical Concepts, Inc. External fixation device systems are comprised of various elements that, when used in conjunction with one another, form bridge constructs to which anchoring screws, wires and/or pins may be attached. Bridge elements are designed to provide a framework for stabilization of bone fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casting or other means of internal fixation.
External fixation elements consist of components such as rails and modular rails, rail-to-rail couplings, rail-to-screw clamps, rail-to-clamp couplings, rail-to-clamp couplings, and clamp-to-clamp couplings. These components are provided in bulk, packaged in nylon pouches, non-sterile, with instructions for steam sterilization by the health care facility.
- Rods, Rails and Modular Rails - Straight rods and rails are external fixation devices of varying lengths (adjustable in the case of modular rods and rails) and dimensions that are used with rail-to-rail, rod-to-rail, rod/rail-to-ring, and rail-to-screw clamps by the surgeon to connect anchoring pins and screws together to form a rigid structure that immobilizes the affected bone or Differences in the dimensions of the rods and rails allow structures. accommodation of a broad range of fracture scenarios and applied loads. All rods and rails have a straight, solid design. These devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel.
- Rings and Ring Segments - Rings and ring segments are circular or semicircular segments manufactured to surround the area of attachment to bone located centrally in the ring. Various attachments are made to the rings or ring segments to stabilize bone fractures or to reduce or extend the length of Tensioned wires or pins are commonly attached to rings and ring bones. segments using clamps designed for this purpose. Multiple ring or ring segment constructs are used to stabilize and structurally support the anatomical structures being treated using a range of configurations and attachments and connectors. The rings and ring segments are manufactured in a range of diameters to allow selection of a size most appropriate to the anatomy and application needed. Rings and ring segments are typically manufactured from one or more of the following materials: anodized aluminum alloys, steel and stainless steel alloys or carbon fiber composites.
- Ring-to-Rod/Rail Clamps - Ring-to-rod/rail clamps are utilized to connect a Ring-to-KourKail Claimps - Iting to today in these attachments are made to form an ring of Ting segment to a routine as required for the particular biomechanical external fixator frame construct us requence to requence typically constructed from needs of the procedure. Italy to rearmials: anodized aluminum alloys, steel and/or stainless steel alloys and titanium alloys.
- Ring-to-Pin or Ring-to-Wire Clamps - Ring-to-pin or ring-to-wire clamps or ring or ring or ring segment to a pin or wire that is normally attached on one side of the ring, passed through the bone, wire that is normally attachment point on the opposite side of the ring where and continue to an attacimient point on another ring to wire clamp. Ring-to-pin or wire clamps are used to secure the ring to a pin, wire or set of pins and wires wire clamps are used to seears assing centrally through the external fixation that are anchored in the octor pare clamps are typically constructed from one Inig. King-to-pin and ring to wire claims alloys, steel and/or stainless steel alloys and titanium alloys.
- Rod/Rail-to-Screw Clamps - Rod/Rail-to-screw clamps are utilized to connect an excential rination fail to a proscrews that are anchored in the bone. DFS System rod/rail-to-screw clamps are V-shaped to provide tri-planar DPS System Todaran to seren. Distraction components are affixed to certain compression of DFS Distal Radius Fixator rod/rail-to-screw clamps to provide Houcis of Dro Distal Rather distal fixator rail. The devices are typically clistiacted from one of the following materials: anodized aluminum and stainless steel.
- Rail-to-Rail Couplings - Rail-to-Rail couplings are multi-element components used to connect one rail to another in a range of positions defined by the individual clamp configuration. They are designed to interconnect a by the individual blanks of rails. These devices are typically constructed specific size of railge of the following materials: anodized aluminum and stainless steel.
- Rod-to-Rail Couplings - Rod-to-Rail couplings are multi-element components used to connect one rod to a rail in a range of positions defined by the individual clamp configuration. They are designed to interconnect a the individual olanip connigation of rods and rails. These devices are typically specific size or a rangor more of the following materials: anodized aluminum and stainless steel.
- Rod-to-Rod Couplings - Rod-to-Rod couplings are multi-element components used to connect one rod to another in a range of positions defined by the individual clamp configuration. They are designed to denned by and meetific size or range of sizes of rods. The devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel.
- Rail-to-Clamp Couplings - Rail-to-clamp couplings are multi-element components used to connect one rail to a clamp in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of rails. The devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel.
- Rod-to-Clamp Couplings - Rod-to-clamp couplings are multi-clement components used to connect one rod to a clamp in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of rods. The devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel.
- Clamp-to-Clamp Couplings - Clamp-to-clamp couplings are multi-element components used to connect one clamp to another in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of clamps. The devices are typically constructed from one or more of the following materials: anodized aluminum or stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Cleaning, packaging, and performance testing demonstrate that the reprocessed devices perform as intended and are safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
510(k) Summary of Safety & Effectiveness
SEP - 6 2005
| Submitter | Vanguard Medical Concepts, Inc.
5307 Great Oak Drive
Lakeland, FL 33815 | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Contact | Heather Crawford, RAC
Director of Regulatory Affairs
863-683-8680 [voice]
863-683-8703 [facsimile]
hcrawford@safe-reuse.com [email] | |
| Date | June 16, 2005 | |
| Device | Trade Name: Vanguard Reprocessed External Fixation Devices EBI DFS Standard Fixator EBI DFS Small Fixator EBI DFS Distal Radius Fixator EBI DFS Hybrid Fixator Common Name: Reprocessed External Fixation Devices Classification: 21 CFR 888.3030 Classification Name: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Product Code: KTT - Class II | |
| Predicate
Devices | External Fixation Devices legally marketed by the following original equipment manufacturer: | |
| | Manufacturer | Trade Name |
| | EBI® Medical Systems, Inc. | DFS® Standard Fixator |
| | EBI® Medical Systems, Inc. | DFS® Small Fixator |
| | EBI® Medical Systems, Inc. | DFS® Distal Radius Fixator |
| | EBI® Medical Systems, Inc. | DFS® Hybrid Fixator |
| Indications
for Use | Reprocessed External Fixation Devices are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery. | |
| Contra-
indications | External fixation devices are contraindicated in patients with mental or neurologic impairment that would interfere with cooperative postoperative care. These devices are not intended for attachment or fixation of screws to the spine. | |
v
1
510(k) Summary of Safety & Effectiveness, continued
Vanguard Reprocessed External Fixation Devices are previously used non-Device invasive orthopedic devices that have been cleaned, inspected, tested, and Description packaged by Vanguard Medical Concepts, Inc. External fixation device systems are comprised of various elements that, when used in conjunction with one another, form bridge constructs to which anchoring screws, wires and/or pins may be attached. Bridge elements are designed to provide a framework for stabilization of bone fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casting or other means of internal fixation.
External fixation elements consist of components such as rails and modular rails, rail-to-rail couplings, rail-to-screw clamps, rail-to-clamp couplings, rail-to-clamp couplings, and clamp-to-clamp couplings. These components are provided in bulk, packaged in nylon pouches, non-sterile, with instructions for steam sterilization by the health care facility.
- Rods. Rails and Modular Rails ~ Straight rods and rails are external fixation 트 devices of varying lengths (adjustable in the case of modular rods and rails) and dimensions that are used with rail-to-rail, rod-to-rail, rod/rail-to-ring, and rail-to-screw clamps by the surgeon to connect anchoring pins and screws together to form a rigid structure that immobilizes the affected bone or Differences in the dimensions of the rods and rails allow structures. accommodation of a broad range of fracture scenarios and applied loads. All rods and rails have a straight, solid design. These devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel.
- Rings and Ring Segments ~ Rings and ring segments are circular or 트 semicircular segments manufactured to surround the area of attachment to bone located centrally in the ring. Various attachments are made to the rings or ring segments to stabilize bone fractures or to reduce or extend the length of Tensioned wires or pins are commonly attached to rings and ring bones. segments using clamps designed for this purpose. Multiple ring or ring segment constructs are used to stabilize and structurally support the anatomical structures being treated using a range of configurations and attachments and connectors. The rings and ring segments are manufactured in a range of diameters to allow selection of a size most appropriate to the anatomy and application needed. Rings and ring segments are typically manufactured from one or more of the following materials: anodized aluminum alloys, steel and stainless steel alloys or carbon fiber composites.
Continued on next page
2
510(k) Summary of Safety & Effectiveness, continued
Device Description (continued)
- Ring-to-Rod/Rail Clamps ~ Ring-to-rod/rail clamps are utilized to connect a 피 Ring-to-KourKail Claimps - Iting to today in these attachments are made to form an ring of Ting segment to a routine as required for the particular biomechanical external fixator frame construct us requence to requence typically constructed from needs of the procedure. Italy to rearmials: anodized aluminum alloys, steel and/or stainless steel alloys and titanium alloys.
- Ring-to-Pin or Ring-to-Wire Clamps ~ Ring-to-pin or ring-to-wire clamps u Ring-to-Fin of Ring-to-Wire Or ring or ring or ring segment to a pin or wire that is normally attached on one side of the ring, passed through the bone, wire that is normally attachment point on the opposite side of the ring where and continue to an attacimient point on another ring to wire clamp. Ring-to-pin or wire clamps are used to secure the ring to a pin, wire or set of pins and wires wire clamps are used to seears assing centrally through the external fixation that are anchored in the octor pare clamps are typically constructed from one Inig. King-to-pin and ring to wire claims alloys, steel and/or stainless steel alloys and titanium alloys.
- Rod/Rail-to-Screw Clamps ~ Rod/Rail-to-screw clamps are utilized to 8 Rour Ran-to-Screw - Califfer - Califfer - Station raily affixed to the bone. connect an excential rination fail to a proscrews that are anchored in the bone.
DFS System rod/rail-to-screw clamps are V-shaped to provide tri-planar DPS System Todaran to seren. Distraction components are affixed to certain compression of DFS Distal Radius Fixator rod/rail-to-screw clamps to provide Houcis of Dro Distal Rather distal fixator rail. The devices are typically clistiacted from one of the following materials: anodized aluminum and stainless steel.
- Rail-to-Rail Couplings ~ Rail-to-Rail couplings are multi-element . Components used to connect one rail to another in a range of positions defined by the individual clamp configuration. They are designed to interconnect a by the individual blanks of rails. These devices are typically constructed specific size of railge of the following materials: anodized aluminum and stainless steel.
- Rod-to-Rail Couplings ~ Rod-to-Rail couplings are multi-element . Kou-to-Kan - Couplines
components used to connect one rod to a rail in a range of positions defined by the individual clamp configuration. They are designed to interconnect a the individual olanip connigation of rods and rails. These devices are typically specific size or a rangor more of the following materials: anodized aluminum and stainless steel.
v
3
510(k) Summary of Safety & Effectiveness, continued
Rod-to-Rod Couplings ~ Rod-to-Rod couplings are multi-element 제 Device components used to connect one rod to another in a range of positions Description defined by the individual clamp configuration. They are designed to (continued) denned by and meetific size or range of sizes of rods. The devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel. Rail-to-Clamp Couplings ~ Rail-to-clamp couplings are multi-element 트 components used to connect one rail to a clamp in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of rails. The devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel. Rod-to-Clamp Couplings ~ Rod-to-clamp couplings are multi-clement 8 components used to connect one rod to a clamp in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of rods. The devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel. Clamp-to-Clamp Couplings ~ Clamp-to-clamp couplings are multi-element 해 components used to connect one clamp to another in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of clamps. The devices are typically constructed from one or more of the following materials: anodized aluminum or stainless steel. Vanguard Reprocessed External Fixation Devices are essentially identical to the Technological Characteristics Original Equipment Manufacturer (OEM) devices. No changes are made to the currently marketed OEM device specifications and the Reprocessed External Fixation Devices possess identical technological characteristics Cleaning, packaging, and performance testing demonstrate that the reprocessed Test Data devices perform as intended and are safe and effective. Based upon the information provided herein and the 510(k) "Substantial Conclusion Equivalence" Decision Making Process Chart, we conclude that Vanguard Reprocessed External Fixation Devices are substantially equivalent to their predicate devices under the Federal Food, Drug and Cosmetic Act.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three curved lines that resemble a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP -6 2005
Ms. Heather Crawford, RAC Director of Regulatory Affairs Vanguard Medical Concepts, Inc. 5307 Great Oak Drive Lakeland, Florida 33815
Received: June 17, 2005
Re: K051616 Trade/Device Name: Vanguard Reprocessed External Fixation Devices (see attached list) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: KTT, LXT Dated: June 16, 2005
Dear Ms. Crawford:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the enactment date of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may), are s roy isions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register_
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fur 6077, accems (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by sellions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2 – Ms. Heather Crawford, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please It you attence of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
signature
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
PS4340: Appendix A: External Fixation Devices – EBI DynaFix™ DFSTM Standard Fixator
Revision: NEW Effective: draft
Page 1 of 16 ...
| 1 | |
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| ------------- | Comments of the consisted and any and any and any and any the film of the |
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| 1 | |
| Catalog # | Description | Representative Image | Mat.(s) |
|---|---|---|---|
| 01000 | DFS Standard Fixator | ||
| Includes: DFS Std Fixator (01001), Modular | |||
| C/D Mechanism 0-5cm (01150), End Cap | |||
| (01175), 5mm Allen Wrench (03110) | Image: DFS Standard Fixator | Anodized | |
| Aluminum, | |||
| Stainless Steel | |||
| 01001 | DFS Standard Fixator | ||
| Includes: DFS Central Body (01110), L | |||
| Telescoping Arm Complete 0-5cm (01010), R | |||
| Telescoping Arm Complete 0-5cm (01020) | Image: DFS Standard Fixator | ||
| 01005 | Standard Fixator Complete - 5mm Allen | ||
| Wrench (03110), C/D Mechanism 0-5cm | |||
| (01150), End Cap (01175), Dynamization | |||
| Component 0-5cm (01160) | Image: Standard Fixator | ||
| 01010 | L Telescoping Arm Complete 0-5cm | Image: L Telescoping Arm | Anodized |
| Aluminum, | |||
| Stainless Steel | |||
| 01030 | L Telescoping Arm 0-8cm | Image: L Telescoping Arm | |
| 01020 | R Telescoping Arm Complete 0-5cm | Image: R Telescoping Arm | Anodized |
| Aluminum, | |||
| Stainless Steel | |||
| 01040 | R Telescoping Arm 0-8cm | Image: R Telescoping Arm | |
| 01045 | L Male Stem 0-5cm | Image: L Male Stem | Anodized |
| Aluminum, | |||
| Catalog # | Description | Representative Image | Mat.(s) |
| 01055 | L Male Stem 0-8cm | Image: L Male Stem 0-8cm | Stainless Steel |
| 01050 | R Male Stem 0-5cm | Image: R Male Stem 0-5cm | Anodized Aluminum, |
| Stainless Steel | |||
| 01060 | R Male Stem 0-8cm | Image: R Male Stem 0-8cm | Anodized Aluminum, |
| Stainless Steel | |||
| 01070 | Female Clamp Complete 0-5cm | Image: Female Clamp Complete 0-5cm | Anodized Aluminum, |
| Stainless Steel | |||
| 01100 | Female Clamp Complete 0-8cm | Image: Female Clamp Complete 0-8cm | |
| 01075 | Female Clamp Base 0-5cm | Image: Female Clamp Base 0-5cm | Anodized Aluminum, |
| Stainless Steel | |||
| 01105 | Female Clamp Base 0-8cm | Image: Female Clamp Base 0-8cm | |
| 01080 | Clamp Cover | Image: Clamp Cover | Anodized Aluminum |
| 01090 | Locking Screw Set | Image: Locking Screw Set | Stainless Steel |
| Page 3 of 16 | |||
| Catalog # | Description | Representative Image | Mat.(s) |
| 01175 | End Cap | Image: End Cap | Anodized Aluminum |
| 01110 | DFS Central Body Component | ||
| Includes: Inner Body Female Rotation Component (01130), Inner Body Male Rotation Component (01135), Left Dual Locking Connector (01120), Right Dual Locking Connector (01115) | Image: DFS Central Body Component | Anodized Aluminum, Stainless Steel | |
| 01115 | Right Dual Locking Connector | Image: Right Dual Locking Connector Right (01115) | Anodized Aluminum, Stainless Steel |
| 01120 | Left Dual Locking Connector | Image: Left Dual Locking Connector Left (01120) | Anodized Aluminum, Stainless Steel |
| 01145 | Inner Body Rotation Component Kit | ||
| Includes: Inner Body Female Rotation Component (01130), Inner Body Male Rotation Component (01135) | Image: Inner Body Rotation Component Kit | Anodized Aluminum, Stainless Steel | |
| 01130 | Inner Body Female Rotation Component | Image: Inner Body Female Rotation Component Female End (01130) | Stainless Steel |
| 01135 | Inner Body Male Rotation Component | Image: Inner Body Male Rotation Component Male End (01135) Inner Body Rotation Complete | Stainless Steel |
| 01140 | Locking Connector Bolt (pack of 4) | ||
| 01160 | Dynamization Component 0-5cm | Image: Dynamization Component 0-5cm | Stainless Steel |
| 01165 | Dynamization Component 0-8cm | Image: Dynamization Component 0-8cm | Stainless Steel |
| Catalog # | Description | Representative Image | Mat.(s) |
| 01180 | Modular C/D Mechanism 0-5cm | Image: Modular C/D Mechanism 0-5cm | Stainless Steel |
| 01185 | Modular C/D Mechanism 0-8cm | Image: Modular C/D Mechanism 0-8cm | Stainless Steel |
| 01430 | Enhanced Access C/D Mechanism 0-5cm | Image: Enhanced Access C/D Mechanism 0-5cm | Stainless Steel, Anodized Aluminum |
| 01435 | Enhanced Access C/D Mechanism 0-8cm | Image: Enhanced Access C/D Mechanism 0-8cm | Stainless Steel |
| 03140 | Wrench for 01430 and 01435 Enhanced Access C/Ds | NO PHOTO AVAILABLE | Stainless Steel |
| 01200 | DFS Convergent T-Clamp Offset | ||
| Includes: Left Clamp Body (1255), Parallel Clamp Cover (1270), Offset Clamp Body (1260), Clamp Cover Locking Bolt (01085) | Image: DFS Convergent T-Clamp Offset | Anodized Aluminum, Stainless Steel | |
| 01250 | DFS Convergent T-Clamp Parallel | ||
| Includes: Parallel Clamp Body (01265), Parallel Clamp Cover (01270), Clamp Cover Bolt (01085) | Image: DFS Convergent T-Clamp Parallel | Anodized Aluminum, Stainless Steel | |
| Page 5 of 16 | |||
| Catalog # | Description | Representative Image | Mat.(s) |
| 01260 | Offset Clamp Body | Image: Offset Clamp Body | Anodized Aluminum, Stainless Steel |
| 01265 | Parallel Clamp Body | AS ABOVE BUT WITH SHALLOW SLOTS | Anodized Aluminum, Stainless Steel |
| 01270 | Parallel Clamp Cover | Image: Parallel Clamp Cover | Anodized Aluminum |
| 01275 | Offset Clamp Cover | Image: Offset Clamp Cover | Anodized Aluminum |
| 01300 | DFS T-Clamp Complete | ||
| Includes: T-Clamp Body (01305), Clamp Cover (01080), T-Clamp Body (01085) | Image: DFS T-Clamp Complete | Anodized Aluminum, Stainless Steel | |
| 01305 | T-Clamp Body | Image: T-Clamp Body | Anodized Aluminum, Stainless Steel |
| 01080 | Clamp Cover | Image: Clamp Cover | Anodized Aluminum |
7
PS4340: Appendix A: External Fixation Devices – EBI DynaFix™ DFSTM Standard Fixator
Revision: NEW Effective: draft
Page 2 of 16
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PS4340: Appendix A: External Fixation Devices – EBI DynaFix™ DFSTM Standard Fixato
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9
S4340: Appendix A: External Fixation Devices – EBI DynaFix™ DFS™ Standard Fixato
Station NEW – Effective: draft
Anodized
Aluminum, Stainless Steel
12
Left Clamp Body
01255
10
PS4340: Appendix A: External Fixation Devices – EBI DynaFix™ DFS™ Standard Fixator
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0
11
| PS4340: Appendix A: External Fixation Devices – EBI DynaFix™ DFS™ Standard Fixator | Effective: draft | and the control of the contract and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the commen | |
|---|---|---|---|
| Revision: NEW | Page 6 of 16 |
| Catalog # | Description | Representative Image | Mat.(s) |
|---|---|---|---|
| 1085 | Clamp Cover Locking Bolt | Image: Clamp Cover Locking Bolt | Stainless Steel |
| 1350 | DFS Ankle Clamp | Image: DFS Ankle Clamp | Anodized Aluminum, Stainless Steel |
| 1400 | DFS Angular Hinge Clamp | Image: DFS Angular Hinge Clamp | Anodized Aluminum, Stainless Steel |
| 1450 | Pivot Body with T-Clamp | Image: Pivot Body with T-Clamp | SIMILAR TO ABOVE BUT ONLY SINGLE AXIS OF ROTATION |
| Anodized Aluminum, Stainless Steel | |||
| Catalog # | Description | Representative Image | Mat.(s) |
| 01460 | Pivot Body with Straight Clamp | Image: Pivot Body with Straight Clamp | Anodized Aluminum, Stainless Steel |
| 01500 | DFS Standard Fixator Supplemental Bone Screw Clamp | ||
| Includes: 150mm Rod (01515), Individual Bone Screw Clamps (01525) | Image: DFS Standard Fixator Supplemental Bone Screw Clamp | Anodized Aluminum, Stainless Steel | |
| 01515 | Supplemental Rod 150mm | Image: Supplemental Rod 150mm | Stainless Steel |
| 01520 | Supplemental Rod 300mm | Image: Supplemental Rod 300mm | Anodized Aluminum, Stainless Steel |
| 01525 | Individual Bone Screw Clamp | Image: Individual Bone Screw Clamp | Anodized Aluminum, Stainless Steel |
| 01700 | Universal Ring Adapter-Style B, Includes Adapter Clamp, Style A and B Bolt Sets | Image: Universal Ring Adapter-Style B, Includes Adapter Clamp, Style A and B Bolt Sets | Anodized Aluminum, Stainless Steel |
| 01705 | Universal Ring Adapter-Style A, Includes Adapter Clamp, Spacers (3), Style A Bolt Set | Image: Universal Ring Adapter-Style A, Includes Adapter Clamp, Spacers (3), Style A Bolt Set | Anodized Aluminum, Stainless Steel |
| 01710 | Universal Ring Adapter Clamp Spacers (3) | Image: Universal Ring Adapter Clamp Spacers (3) | Anodized Aluminum |
| 01735 | Adapter Clamp Bolt Set - Style A Used with Drilled Ring | Image: Adapter Clamp Bolt Set - Style A Used with Drilled Ring | Stainless Steel |
| 01740 | Adapter Clamp Bolt Set - Style B Used with Solid Ring | Image: Adapter Clamp Bolt Set - Style B Used with Solid Ring | Stainless Steel |
.
:
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PS4340: Appendix A: External Fixation Devices – EBI DynaFixTM DFSTM Standard Fixato
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PS4340: Appendix A: External Fixation Devices – EBI DynaFix™ DFS™ Standard Fixator
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ri. 11 ( t P m
| Dynafix DFS Small Fixator | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Anodized | |||||||||
| Aluminum, | |||||||||
| Stainless Steel | Anodized | ||||||||
| Aluminum, | |||||||||
| Stainless Steel | Anodized | ||||||||
| Aluminum, | |||||||||
| Stainless Steel | |||||||||
| 02000 | DFS Small Fixator Complete - Includes: DFS | ||||||||
| Small Fixator (02001), C/D Mechanism 0-5mm | |||||||||
| (02148), Small End Cap (02175), 5mm Allen | |||||||||
| Wrench (03110) | 02001 | DFS Small Fixator - Includes: Small Central | |||||||
| Body Component Complete (02110), Small L | |||||||||
| Telescoping Arm 0-3cm (02010), Small R | |||||||||
| Telescoping Arm 0-3cm (02020) | 02005 | DFS Small Fixator Complete with | |||||||
| Dynamization Component - Includes: C/D | |||||||||
| Mechanism 0-3cm (02180), Dynamization | |||||||||
| Component 0-3cm (02155), Small End Cap | |||||||||
| (02175), 5mm Allen Wrench (03110) | 02010 | DFS Small L Telescoping Arm (0-3cm) | |||||||
| Complete | |||||||||
| Includes: 02050, 02030 | 02025 | DFS Small L Telescoping Arm (0-5cm) | |||||||
| Complete | |||||||||
| Includes: | |||||||||
| 02020 | DFS Small R Telescoping Arm (0-3cm) | ||||||||
| Complete | |||||||||
| Includes: 02055, 02040 | 02026 | DFS Small R Telescoping Arm (0-5cm) | |||||||
| Complete | |||||||||
| Includes: | 02030 | DFS Small L Male Stem (0-3cm) | 02045 | DFS Small L Male Stem (0-5cm) |
14
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PS4340: Appendix A: External Fixation Devices – EBI DynaFix™ DFSTM Standard Fixato
Revision: NEW Effective: draft
Page 9 of 16
| 02040 | DFS Small R Male Stem (0-3cm) | ||
|---|---|---|---|
| 02046 | DFS Small R Male Stem (0-5cm) | ||
| 02050 | Small L Female Clamp Complete (0-3cm) | ||
| Includes: | Anodized | ||
| Aluminum, | |||
| Stainless Steel | |||
| 02055 | Small R Female Clamp Complete (0-3cm) | ||
| Includes: | |||
| 02060 | Small L Clamp Base (0-3cm) | Anodized | |
| Aluminum, | |||
| Stainless Steel | |||
| 02065 | Small R Clamp Base (0-3cm) | ||
| 02078 | Small Clamp Cover (0-3cm) | Anodized | |
| Aluminum | |||
| 02070 | Small Female Clamp Complete (0-5cm) | ||
| Includes: | PHOTO SIMILAR TO 2050 BUT LONGER | ||
| (AMBIDEXTROUS) | Anodized | ||
| Aluminum, | |||
| Stainless Steel | |||
| 02075 | Small Female Clamp Base (0-5cm) | PHOTO SIMILAR TO 2060 BUT LONGER | |
| (AMBIDEXTROUS) | Anodized | ||
| Aluminum, | |||
| Stainless Steel | |||
| 02080 | Small Clamp Cover (0-5cm) | PHOTO SIMILAR TO 2078 BUT LONGER | Anodized |
| Aluminum | |||
| 02085 | Small Clamp Cover Locking Bolt | Stainless Steel | |
| 02090 | Small Locking Set Screw | Stainless Steel |
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PS4340: Appendix A: External Fixation Devices – EBI DynaFix™ DFS™ Standard Fixator
Revision: NEW Effective: draft
Page 10 of 16
| Page 10 of 16 | ||
|---|---|---|
| 02175 | Small End Cap | Anodized |
| Aluminum | ||
| 02110 | DFS Small Central Body Component Complete | |
| Includes: 02130, 02135, 02120, 02115 | Anodized | |
| Aluminum, | ||
| Stainless Steel | ||
| 02115 | Small R Dual Locking Connector Component | Anodized |
| Aluminum, | ||
| Stainless Steel | ||
| 02120 | Small L Dual Locking Connector Component | |
| 02130 | Small Inner Body Female Rotational | |
| Component | Anodized | |
| Aluminum, | ||
| Stainless Steel | ||
| 02135 | Small Inner Body Male Rotational Component | |
| 02140 | Small Locking Connector Bolt (4 pack) | Stainless Steel |
| 02145 | Small Inner Body Rotational Component | |
| Complete | ||
| Includes: | Anodized | |
| Aluminum, | ||
| Stainless Steel | ||
| 02155 | Small Dynamization Component (0-3cm) | Stainless Steel |
| 02160 | Small Dynamization Component (0-5cm) | Stainless Steel |
| 02180 | Small Modular C/D Mechanism (0-3cm) | |
| (replaces 02148) | Stainless Steel | |
| 02185 | Small Modular C/D Mechanism (0-5cm) | |
| (replaces 02150) | Image: Small Modular C/D Mechanism | |
| 02200 | DFS Small Convergent T-Clamp Offset | Anodized Aluminum, Stainless Steel |
| 02250 | DFS Small Convergent T-Clamp Parallel | |
| Includes: 02265, 02270, 02085 | SAME AS ABOVE BUT WITH EVEN PIN | |
| DEPTH SLOTS | ||
| 02255 | Small Left Clamp Body | Anodized Aluminum, Stainless Steel |
| Anodized Aluminum, Stainless Steel | ||
| 02260 | Small Offset Clamp Body | Anodized Aluminum, Stainless Steel |
| 02265 | Small Parallel Clamp Body | SAME AS ABOVE BUT WITH SHALLOW |
| PIN SLOTS | ||
| 02270 | Small Parallel Clamp Cover | Anodized Aluminum, Stainless Steel |
| Anodized Aluminum |
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P84340: Appendix A: External Fixation Devices – EBI DynaFixTM DFS™ Standard Fixator
Revision: NEW Effective: draft
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| 02275 | Small Offset Clamp Cover | Anodized
Aluminum | Image: Small Offset Clamp Cover |
|-------|-------------------------------|------------------------------------------|---------------------------------------------------------------|
| 02320 | Small 3-Hole T-Clamp Complete | Anodized
Aluminum,
Stainless Steel | Image: Small 3-Hole T-Clamp Complete |
| 02325 | Small 3-Hole T-Clamp Body | Anodized
Aluminum,
Stainless Steel | SAME AS ABOVE BUT W/O TOP
Image: Small 3-Hole T-Clamp Body |
(
18
| DFS® (DRS) Distal Radius Fixator | |||
|---|---|---|---|
| 04000 | Distal Radius Fixator Complete | ||
| Includes: Distal Radius Fixator (04001), 3mm | |||
| T-Wrench (05045) | Image: Distal Radius Fixator Complete | Anodized | |
| Aluminum, | |||
| Stainless Steel | |||
| 04001 | DFS Distal Radius Fixator | ||
| Includes: Central Component (04005), Bone | |||
| Screw Clamp (04025), Distal Fixator Rail | |||
| (04010), Proximal Fixator Rail (04020) | Image: DFS Distal Radius Fixator | Anodized | |
| Aluminum, | |||
| Stainless Steel | |||
| 04002 | DFS Distal Radius Fixator with Distration | ||
| Module Complete | AS BELOW BUT WITH 3mm T-WRENCH | ||
| ADDED AS KIT | Anodized | ||
| Aluminum, | |||
| Stainless Steel | |||
| 04003 | Includes: Distral Radius Fixator w/Distraction | ||
| Module (04003), 3mm T-Wrench (05045) | |||
| DFS Distal Radius Fixator with Distraction | |||
| Module | |||
| Includes: Central Component (04005), Bone | |||
| Screw Clamp (04025), Bone Screw Clamp | |||
| w/Distraction Module (04030), Distal Fixator | |||
| Rail (04010), Proximal Fixator Rail (04020) | Image: DFS Distal Radius Fixator with Distraction Module | Anodized | |
| Aluminum, | |||
| Stainless Steel | |||
| 04025 | Bone Screw Clamp | Image: Bone Screw Clamp | Anodized |
| Aluminum, | |||
| Stainless Steel | |||
| 04030 | Bone Screw Clamp with Distraction Module | Image: Bone Screw Clamp with Distraction Module | Anodized |
| Aluminum, | |||
| Stainless Steel | |||
| 04005 | Central Component | Anodized | |
| Aluminum, | |||
| Stainless Steel | |||
| 04010 | Distal Fixator Rail | Stainless Steel | |
| 04020 | Proximal Fixator Rail | Stainless Steel | |
| 04050 | Clamp Cover Locking Screw | Stainless Steel | |
| 04055 | Fixator Rail Locking Screw | Stainless Steel | |
| 04056 | Distraction Module Fixator Rail Locking Screw | Stainless Steel | |
| 04015 | Collet Locking Screw (2 each) | Stainless Steel |
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PS4340: Appendix A: External Fixation Devices – EBI DynaFix™ DFS™ Standard Fixat
Revision: NEW Effective: draft
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PS4340: Appendix A: External Fixation Devices – EBI DynaFix™ DFS™ Standard Fixat
Revision: NEW Effective: draft
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| CHATCH THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE | |
|---|---|
| יישורים במקום היישוב המועד העירונים העובדים במקום המועד המועד של היישובים במידעים ב | |
| re rate | |
| A STATE THE STATES PARTY PLANE | —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— |
| am ATT | |
| a opportion for - | |
| 1 14 114 11 | |
| Land States and Concession Company of Children Comments of | |
| Comments of the count of the consisted to a more of the consisted to |
・・
| 13005 | 130mm 1/3 Ring | | Anodized
Aluminum | | | |
|-------|------------------------------|--|----------------------|----------------|----------------------|------------------------------------------|
| 13020 | 150mm 1/3 Ring | | | 150mm 1/3 Ring | Anodized
Aluminum | |
| 13035 | 180mm 1/3 Ring | | | 220mm 1/3 Ring | | |
| 13050 | 220mm 1/3 Ring | | | | | |
| 13010 | 130mm 2/3 Ring | | | | | |
| 13025 | 150mm 2/3 Ring | | | 150mm 2/3 Ring | | |
| 13040 | 180mm 2/3 Ring | | | 220mm 2/3 Ring | | |
| 13055 | 220mm 2/3 Ring | | | | | |
| 13060 | Ring Locking Bolt (1/Pkg.) | | | | | Stainless Steel |
| 13065 | Ring to Fixator Connector | | | | | Anodized
Aluminum,
Stainless Steel |
| 13070 | Variable Wire Carriages (x6) | | | | | Anodized
Aluminum,
Stainless Steel |
| 13080 | Variable Bone Screw Carriage | | | | | Anodized
Aluminum,
Stainless Steel |
| 13200 | Left Ring Fixator Assembly | | | | | |
| 13210 | Right Ring Fixator Assembly | | | | | |
21
PS4340 Appendix A: External Fixation Devices – EBI DynaFix™ DFS™ Standard Fixato
Revision: NEW Effective: draft
Page 16 of 16
| Page 16 of 16 | |||
|---|---|---|---|
| 14010 | Rod-to-Rod Connector | Stainless Steel | |
| 14240 | Vision Post | Stainless Steel | |
| 14060 | Three Hole Clamp | Anodized | |
| Aluminum, | |||
| Stainless Steel | |||
| 14090 | Five Hole Clamp | ||
| 14160 | 8mm Carbon Fiber Rod (Length 150mm) | Carbon Fiber | |
| 14165 | Carbon Rod (9.5mm x 200mm) | ||
| 14170 | 9.5mm Carbon Rod (Length 250mm) | ||
| 14175 | 8mm Carbon Fiber Rod (Length 300mm) | ||
| 14180 | 8mm Carbon Fiber Rod (Length 340mm) | ||
| 14185 | 9.5mm Carbon Rod (Length 400mm) | ||
| 90100 | Left Ankle Kit | Anodized | |
| Aluminum, | |||
| Stainless Steel | |||
| 90105 | Right Ankle Kit | Anodized | |
| Aluminum, | |||
| Stainless Steel |
.
22
Indications for Use
510(k) Number (if known):
Device Name: Vanguard Reprocessed External Fixation Devices
Indications for Use:
Reprocessed External Fixation Devices are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.
: Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Postorative, Page 1 of 1 and Neurological Devices 510(k) Number_16 / ڪلڪلڪلڪرڪ i v
011