Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices

K180580 · Surgical Instrument Service and Savings, Inc. · KTT · Jul 27, 2018 · Orthopedic

Device Facts

• Record ID: K180580
• Device Name: Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices
• Applicant: Surgical Instrument Service and Savings, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Jul 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation devices are intended to be used on adults or pediatric patients as required and are intended to be used for fracture fixation (open and closed): post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; joint arthrodesis; and management of comminuted intractures of the distal radius. Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation devices are for single use only.

Device Story

Reprocessed orthopedic external fixation system; includes clamps, posts, and bars. Used for fracture management, joint contracture correction, and limb lengthening. Operates by providing rigid skeletal stabilization. Used in clinical/surgical settings by physicians. Reprocessing involves cleaning and sterilization of OEM devices; no changes to design, materials, or intended use. Provides mechanical stability to bone segments to facilitate healing.

Clinical Evidence

Bench testing only. Evaluated via functional performance studies: simulated use, artificial soiling, structural integrity, carbon rod stiffness (4-point bend test, pre/post-conditioning), cyclical axial compression/tension bending, disassembly/reassembly (pre/post-sterilization), and cleaning efficacy (residual protein/carbohydrate).

Technological Characteristics

Materials: stainless steel, titanium, carbon fiber, aluminum. Principle: mechanical external fixation. Form factor: various clamps, bars, and posts. Sterilization: reprocessed/re-sterilized. No software or energy source.

Indications for Use

Indicated for adults and pediatric patients requiring fracture fixation (open/closed), management of joint contractures, fractures requiring distraction, pseudoarthrosis, non-union of long bones, limb lengthening, correction of bony/soft tissue deformities or defects, joint arthrodesis, and comminuted intra-articular distal radius fractures.

Regulatory Classification

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.

Predicate Devices

• Smith & Nephew Jet-X Bar System Clamps, Bars and Posts - MR Conditional (K072212)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Surgical Instrument Service and Savings Inc Stephanie Mays Regulatory Specialist, Quality Assurance/Regulatory Affairs (dba Medline ReNewal) 1500 NE Hemlock Ave Redmond, Oregon 97756

July 27. 2018

# Re: K180580

Trade/Device Name: Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT Dated: June 23, 2018 Received: June 25, 2018

# Dear Stephanie Mays:

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 commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure: Reprocessed List

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| Catalog No. | Description |
|-------------|----------------------------------------------------|
| 7106-2001 | JET-X Bar to pin clamp 10.5mm bar to 5mm pin |
| 7106-2002 | JET-X Bar to bar clamp 10.5mm bar |
| 7106-2004 | JET-X Bar to ring clamp |
| 7106-2005 | JET-X Multiple pin clamp 10.5mm bar to 5mm pin |
| 7107-0343 | JET-X Frame Stabilizer Tool |
| 7106-4004 | JET-X Bar to ring clamp |
| 7106-4005 | JET-X Bar Multiple Pin Clamp |
| 7106-2009 | JET-X Freedom clamp 6mm bar to 5mm pin |
| 7106-2010 | JET-X Mini bar 10.5mm to 4mm pin clamp |
| 7106-2011 | JET-X Mini bar 6mm to 4mm pin clamp |
| 7106-2012 | JET-X Mini Bar to Pin Clamp 6mm to 6mm |
| 7106-2015 | JET-X Mini multiple pin clamp |
| 7106-2016 | JET-X Mini Double pin clamp with ball joint |
| 7106-2019 | JET-X Mini bar 6mm to 10.5mm bar clamp |
| 7106-2721 | JET-X Ankle Clamp |
| 7106-2722 | JET-X Freedom Bar to Ring Clamp 10.5mm Bar to Ring |
| 7106-4001 | JET-X Freedom clamp 10.5mm bar to 5mm pin |
| 7106-4002 | JET-X Freedom clamp 10.5mm bar to 10.5mm bar |
| 7106-4009 | JET-X Bar to pin clamp |
| 7106-4010 | JET-X Mini freedom clamp 10.5mm bar to 4mm pin |
| 7106-4011 | JET-X Mini freedom clamp 6mm bar to 4mm pin |
| 7106-4012 | JET-X Mini freedom clamp 6mm bar to 6mm pin |
| 7106-4015 | JET-X Mini multiple pin clamp |
| 7106-4016 | JET-X Mini double pin clamp with ball joint |
| 7106-4019 | JET-X Freedom clamp 10.5mm bar to 6mm pin |
| 7106-7372 | JET-X Quick clamp 10.5mm bar to 5mm pin |
| 7106-7374 | JET-X Quick clamp 10.5mm bar to 10.5mm pin |
| 7106-7375 | JET-X 4 Hole Pin Clamp |
| 7106-7376 | JET-X 6 Hole Pin Clamp |
| 7106-7371 | JET-X Mini Quick clamp 10.5mm to 4mm |
| 7106-7373 | JET-X Mini Quick clamp 10.5mm bar to 6mm pin |
| 7106-7377 | JET-X Quick Clamp 6mm to 4mm |
| 7106-7378 | JET-X Quick Clamp 6mm to 6mm |
| 7106-7380 | JET-X Quick Clamp 6mm to 5mm |
| 7106-2160 | JET-X L-Bar 10.5mm |
| 7106-2180 | JET-X V-Bar 10.5mm |
| 7106-2100 | JET-X Bar 10.5mm x 100mm |
| 7106-2150 | JET-X Bar 10.5mm x 150mm |
| 7106-2200 | JET-X Bar 10.5mm x 200mm |
| 7106-2250 | JET-X Bar 10.5mm x 250mm |
| 7106-2300 | JET-X Bar 10.5mm x 300mm |
| 7106-2350 | JET-X Bar 10.5mm x 350mm |
| 7106-2400 | JET-X Bar 10.5mm x 400mm |
| 7106-2500 | JET-X Bar 10.5mm x 500mm |
| 7106-2600 | JET-X Bar 10.5mm x 600mm |
| 7106-5050 | JET-X Mini Composite Bar 6mm x 50mm |
| 7106-5075 | JET-X Composite Bar 6mm x 75mm |
| 7106-5110 | JET-X Composite Bar 6mm x 110mm |
| 7106-5150 | JET-X Composite Bar 6mm x 150mm |
| 7106-5185 | JET-X Composite Bar 6mm x 185mm |
| 7106-5225 | JET-X Composite Bar 6mm x 225mm |
| 7106-5180 | JET-X Composite V-Bar 6mm |
| 7106-5226 | JET-X Off-Set Bar 6mm |
| 7106-7379 | JET-X Straight Post |
| 7106-7381 | JET-X 30° Angled Post |
| 7106-7382 | JET-X Freedom Post |

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# Indications for Use

510(k) Number (if known) K180580

#### Device Name

Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Systems

#### Indications for Use (Describe)

Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation devices are intended to be used on adults or pediatric patients as required and are intended to be used for fracture fixation (open and closed): post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; joint arthrodesis; and management of comminuted intractures of the distal radius. Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation devices are for single use only.

Type of Use (Select one or both, as applicable)

| <span style="font-family: sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Image /page/5/Picture/1 description: The image contains two logos side by side. The logo on the left is for Medline, and it features the word "MEDLINE" in a sans-serif font, with a star-like symbol above it, all in white against a blue background. The logo on the right is for ReNewal Full Circle Reprocessing, with "ReNewal" in green and blue, and "Full Circle Reprocessing" in a smaller font below it.

Traditional 510(k) Notification Medline ReNewal Reprocessed Smith & Nephew External Fixation Devices

# 5.0 510(k) Summary

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92.

| Submitter/<br>Owner | Surgical Instrument Service and Savings (dba Medline ReNewal)<br>1500 NE Hemlock Ave.<br>Redmond, OR 97756 | | |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|--|
| Prepared<br>by/Contact<br>Name | Stephanie Boyle Mays<br>Regulatory Affairs Specialist, Quality Assurance/Regulatory Affairs<br>P: 541-516-4205 • F: 541-923-3375 • E:[e-mail] | | |
| Date Prepared | February 28, 2108 | | |
| Device Name<br>and<br>Classification | Proprietary/Trade<br>Name: | Medline ReNewal Reprocessed Smith & Nephew Jet-X<br>External Fixation Systems Devices | |
| | Regulatory<br>Name/Reference: | Smooth or threaded metallic bone fixation fastener,<br>21 CFR § 888.3040 | |
| | Regulatory Class: | Class II | |
| | Product Code: | KTT | |
| | Panel: | Orthopedic | |
| | 510(k) number: | K072212 | |
| Predicate<br>Device | Proprietary/Trade<br>Name: | Smith & Nephew Jet-X Bar System Clamps, Bars and<br>Posts - MR Conditional | |
| | Regulatory<br>Name/Reference | Smooth or threaded metallic bone fixation fastener,<br>21 CFR § 888.3040 | |
| | Regulatory Class | Class II | |
| | Product Code: | KTT | |
| | Panel: | Orthopedic | |
| | Manufacturer: | Smith & Nephew, Inc.,<br>1450 Brooks Rd., Memphis, TN 38116 | |
| Device<br>Description | The Medline ReNewal Reprocessed Smith & Nephew Jet-X External<br>Fixation systems. The devices consist of various clamps, posts, and bars,<br>which are used to in the management of bone fractures and reconstructive,<br>as well as corrective, orthopedic surgery. The materials used in their<br>manufacture are chosen to address a wide range of applications. These<br>devices have been designed to allow for the appropriate amount of rigidity<br>and stability. | | |
| Statement of<br>Intended<br>Use/Indications<br>for Use | Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation<br>devices are intended to be used on adults or pediatric patients as required<br>and are intended to be used for fracture fixation (open and closed): post-<br>traumatic joint contracture which has resulted in loss of range of motion;<br>fractures and disease which generally may result in joint contractures or<br>loss of range of motion and fractures requiring distraction; pseudoarthrosis<br>or non-union of long bones; limb lengthening by epiphyseal or metaphyseal<br>distraction; correction of bony or soft tissue deformity; correction of<br>segmental bony or soft tissue defects; joint arthrodesis; and management<br>of comminuted intra-articular fractures of the distal radius. Medline | | |

Image /page/5/Picture/6 description: The image is completely black, lacking any discernible features or content. The darkness dominates the entire frame, creating a void-like impression. There are no shapes, lines, or textures visible, resulting in a uniform and featureless composition. The absence of light and detail makes it impossible to identify any objects or subjects within the image.

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Image /page/6/Picture/1 description: The image shows two logos side by side. The logo on the left is for Medline, and it features the word "MEDLINE" in bold, white letters against a blue background, accompanied by a stylized white graphic. The logo on the right is for Renewal, with the "Re" in green and the "newal" in blue, and below it, the words "Full Circle Reprocessing" in blue.

| ReNewal Reprocessed Smith & Nephew Jet-X External Fixation devices<br>are for single use only. | | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Technological<br>Characteristics | The principle of operation of the reprocessed devices is identical to that of<br>the predicates. There are no changes in intended use, performance<br>specifications or method of operation. These devices utilize stainless steel,<br>titanium, carbon fiber and aluminum materials and technological<br>characteristics that are very similar when compared to the predicate<br>devices. | |
| Performance<br>Testing | The functional characteristics of the subject device have been evaluated<br>and have been determined to be substantially equivalent to the predicate<br>device based on the following tests:<br>• Functional performance studies: | |
| | ○ simulated use and artificial soiling; and<br>○ structural integrity;<br>○ carbon rod stiffness per the 4-point bend test<br>(pre-conditioning);<br>○ cyclical axial compression and tension bending test;<br>○ carbon rod stiffness per the 4-point bend test<br>(post-conditioning); and<br>○ disassembly and reassembly (pre-and post-sterilization).<br>• Cleaning:<br>○ visual inspection;<br>○ cleaning efficacy (residual protein and residual carbohydrate). | |
| Device Models | Catalog No. | Description |
| | 7106-2001 | JET-X Bar to pin clamp 10.5mm bar to 5mm pin |
| | 7106-2002 | JET-X Bar to bar clamp 10.5mm bar |
| | 7106-2004 | JET-X Bar to ring clamp |
| | 7106-2005 | JET-X Multiple pin clamp 10.5mm bar to 5mm pin |
| | 7107-0343 | JET-X Frame Stabilizer Tool |
| | 7106-4004 | JET-X Bar to ring clamp |
| | 7106-4005 | JET-X Bar Multiple Pin Clamp |
| | 7106-2009 | JET-X Freedom clamp 6mm bar to 5mm pin |
| | 7106-2010 | JET-X Mini bar 10.5mm to 4mm pin clamp |
| | 7106-2011 | JET-X Mini bar 6mm to 4mm pin clamp |
| | 7106-2012 | JET-X Mini Bar to Pin Clamp 6mm to 6mm |
| | 7106-2015 | JET-X Mini multiple pin clamp |
| | 7106-2016 | JET-X Mini Double pin clamp with ball joint |
| | 7106-2019 | JET-X Mini bar 6mm to 10.5mm bar clamp |
| | 7106-2721 | JET-X Ankle Clamp |
| | 7106-2722 | JET-X Freedom Bar to Ring Clamp 10.5mm Bar to Ring |
| | 7106-4001 | JET-X Freedom clamp 10.5mm bar to 5mm pin |
| | 7106-4002 | JET-X Freedom clamp 10.5mm bar to 10.5mm bar |
| | 7106-4009 | JET-X Bar to pin clamp |
| | 7106-4010 | JET-X Mini freedom clamp 10.5mm bar to 4mm pin |
| Catalog No. | Description | |
| 7106-4012 | JET-X Mini freedom clamp 6mm bar to 6mm pin | |
| 7106-4015 | JET-X Mini multiple pin clamp | |
| 7106-4016 | JET-X Mini double pin clamp with ball joint | |
| 7106-4019 | JET-X Freedom clamp 10.5mm bar to 6mm pin | |
| 7106-7372 | JET-X Quick clamp 10.5mm bar to 5mm pin | |
| 7106-7374 | JET-X Quick clamp 10.5mm bar to 10.5mm pin | |
| 7106-7375 | JET-X 4 Hole Pin Clamp | |
| 7106-7376 | JET-X 6 Hole Pin Clamp | |
| 7106-7371 | JET-X Mini Quick clamp 10.5mm to 4mm | |
| 7106-7373 | JET-X Mini Quick clamp 10.5mm bar to 6mm pin | |
| 7106-7377 | JET-X Quick Clamp 6mm to 4mm | |
| 7106-7378 | JET-X Quick Clamp 6mm to 6mm | |
| 7106-7380 | JET-X Quick Clamp 6mm to 5mm | |
| 7106-2160 | JET-X L-Bar 10.5mm | |
| 7106-2180 | JET-X V-Bar 10.5mm | |
| 7106-2100 | JET-X Bar 10.5mm x 100mm | |
| 7106-2150 | JET-X Bar 10.5mm x 150mm | |
| 7106-2200 | JET-X Bar 10.5mm x 200mm | |
| 7106-2250 | JET-X Bar 10.5mm x 250mm | |
| 7106-2300 | JET-X Bar 10.5mm x 300mm | |
| 7106-2350 | JET-X Bar 10.5mm x 350mm | |
| 7106-2400 | JET-X Bar 10.5mm x 400mm | |
| 7106-2500 | JET-X Bar 10.5mm x 500mm | |
| 7106-2600 | JET-X Bar 10.5mm x 600mm | |
| 7106-5050 | JET-X Mini Composite Bar 6mm x 50mm | |
| 7106-5075 | JET-X Composite Bar 6mm x 75mm | |
| 7106-5110 | JET-X Composite Bar 6mm x 110mm | |
| 7106-5150 | JET-X Composite Bar 6mm x 150mm | |
| 7106-5185 | JET-X Composite Bar 6mm x 185mm | |
| 7106-5225 | JET-X Composite Bar 6mm x 225mm | |
| 7106-5180 | JET-X Composite V-Bar 6mm | |
| 7106-5226 | JET-X Off-Set Bar 6mm | |
| 7106-7379 | JET-X Straight Post | |
| 7106-7381 | JET-X 30° Angled Post | |
| 7106-7382 | JET-X Freedom Post | |

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Image /page/7/Picture/1 description: The image contains two logos side by side. The first logo is for Medline, and it features the word "MEDLINE" in white letters on a blue background, with a star-like symbol above the word. The second logo is for ReNewal Full Circle Reprocessing, with the word "ReNewal" in green and blue letters and the words "Full Circle Reprocessing" in smaller black letters below.

Device Model (concluded)

(concluded)

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Image /page/8/Picture/1 description: The image shows two logos side by side. The logo on the left is for Medline, and it features a blue background with a white star-like symbol and the word "MEDLINE" in white letters. The logo on the right is for ReNewal, and it features the word "ReNewal" in green and blue letters, with the words "Full Circle Reprocessing" in smaller blue letters below.

Traditional 510(k) Notification Medline ReNewal Reprocessed Smith & Nephew External Fixation Devices

| Device<br>Characteristics | Predicate<br>Smith & Nephew<br>Jet-X Bar System<br>Clamps, Bars and Posts | Proposed<br>Medline ReNewal<br>Reprocessed<br>Smith & Nephew Jet-X<br>External Fixation Devices | Comparison<br>Same devices;<br>original and<br>reprocessed |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| 510(k) Number | K072212 | TBD | N/A |
| Common Name | External Fixation System | External Fixation System | Same |
| Regulation No. | 888.3040 | 888.3040 | Same |
| Product Code | KTT | KTT | Same |
| Intended Use | The devices described<br>herein are intended to be<br>used on adults or pediatric<br>patients as required and<br…