(58 days)
The Medline ReNewal Reprocessed Stryker External Fixation Devices are external fixation frame components for use with components of the Hoffmann 3 MR Conditional. Hoffmann II MR Conditional. Hoffmann II Compact MR Conditional and Hoffmann II Compact external fixation systems. They are intended to provide stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts or other mean of internal fixations for use of external fixation devices include:
- · bone fracture fixation;
- · osteotomy:
- · arthrodesis:
- · correction of deformity; revision procedure where other treatments or devices have been unsuccessful; and
- · bone reconstruction procedures.
The Medline ReNewal Reprocessed Stryker External Fixation Devices are intended to provide temporary stabilization of open and/or unstable fractures where soft tissue injury may preclude the use of other fracture treatments. Additionally, the devices may be used for elective orthopedic interventions such as limb lengthening. Devices in the scope of this document include various rods and clamps/connectors that are assembled external to the operative or injury focus and will not be in direct patient contact.
This document describes the 510(k) premarket notification for Medline ReNewal Reprocessed Stryker External Fixation Devices. It focuses on demonstrating substantial equivalence to predicate devices through performance testing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table with numerical acceptance criteria and reported device performance values. Instead, it broadly states that "The functional characteristics of the subject device have been evaluated and have been determined to be substantially equivalent to the predicate device based on the following tests."
The functional performance studies mentioned are:
- Simulated Use and Artificial Soiling: Implies testing the device under simulated clinical conditions, including exposure to typical biological contaminants. The acceptance criterion would likely be successful cleaning and restoration of functionality after reprocessing.
- Structural Integrity: This would involve mechanical testing to ensure the reprocessed device maintains its structural strength and integrity. Acceptance criteria would likely be a comparison to the original equipment manufacturer (OEM) specifications or to the predicate device's performance, ensuring no degradation after reprocessing.
- Carbon Rod Stiffness per the 4-point bend test (pre-conditioning): Measures the stiffness of carbon rods before they are subjected to simulated use or conditioning. Acceptance criterion would be that the stiffness matches or is within an acceptable range of the OEM or predicate device specifications.
- Cyclical Axial Compression and Tension Bending Test: Evaluates the fatigue life and mechanical durability of the device under repeated loading. Acceptance criterion would be successful completion of a specified number of cycles without failure, demonstrating performance equivalent to the predicate.
- Carbon Rod Stiffness per the 4-point bend test (post conditioning): Measures the stiffness of carbon rods after they have undergone simulated use or conditioning. The acceptance criterion would be that the stiffness remains within acceptable limits and comparable to the predicate device, indicating no significant material degradation from reprocessing or use.
- Disassembly and Reassembly (pre-and post-sterilization): Assesses the ability of the device to be taken apart and put back together correctly and safely, both before its first use (after reprocessing) and after sterilization. Acceptance would involve visual inspection and functional checks to ensure proper fit, function, and absence of damage.
- Cleaning:
- Visual Inspection: Ensures no visible residue remains after cleaning. Acceptance criterion is no visible residue.
- Cleaning Efficacy (residual protein and residual carbohydrate): Quantifies residual organic matter after cleaning. Acceptance criteria would be specific threshold levels for residual protein and carbohydrate, typically very low to ensure patient safety and effective sterilization.
Reported Device Performance: The document generally states that the device performance for these tests has been "determined to be substantially equivalent to the predicate device." Specific numerical results for each test are not provided in this summary.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes used for each of the performance tests.
The data provenance is implied to be laboratory testing conducted by Medline ReNewal, as part of their 510(k) submission. It would be considered prospective for the purpose of demonstrating the safety and effectiveness of their reprocessed devices. The country of origin of the data is not explicitly stated but is likely the USA, where Medline ReNewal is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The type of testing described (mechanical, cleaning efficacy) typically relies on objective measurements against established engineering specifications rather than expert consensus on a "ground truth" in the way a diagnostic AI might. Therefore, the concept of "experts establishing ground truth" in the context of clinical images or conditions is less applicable here. The "ground truth" for the performance tests would be the established specifications of the original device and recognized industry standards for reprocessed medical devices.
4. Adjudication Method for the Test Set
This information is not provided and is generally not applicable to the type of performance testing described for a reprocessed external fixation device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple readers evaluating medical images or patient outcomes, which is not the nature of this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not what this reprocessed medical device is.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
A standalone performance evaluation was not done. This concept is relevant for AI algorithms. The device under consideration is a physical medical device (reprocessed external fixation components), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing described would be:
- Original Equipment Manufacturer (OEM) Specifications: The performance characteristics (e.g., structural integrity, stiffness) of the new, original Stryker External Fixation Devices.
- Industry Standards: Applicable standards for mechanical testing of external fixation devices and cleaning/sterilization of reprocessed medical devices.
- Objective Measurements: Results of physical, chemical, and mechanical tests conducted on the reprocessed devices.
8. The Sample Size for the Training Set
The concept of a "training set" is relevant for machine learning or AI models. This document describes a reprocessed physical medical device, not an AI or algorithm. Therefore, there is no training set in the context of AI. The "training" for the reprocessing process itself would involve establishing and validating the reprocessing procedures (cleaning, disinfection, sterilization, functional testing), which were applied to a set number of devices for the performance studies mentioned. The document does not specify the number of devices used to develop or validate the reprocessing protocols.
9. How the Ground Truth for the Training Set Was Established
Since there is no AI training set, this question is not applicable. The "ground truth" for the reprocessing procedures would be validated through rigorous testing against established industry standards and internal quality control measures to ensure that the reprocessed devices meet the same performance and safety standards as the original devices.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles suggesting a sense of community and support. The profiles are rendered in a dark color, creating a strong contrast against the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 28, 2016
Surgical Instrument Service and Savings Inc. Brandi J. Panteleon Director, Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756
Re: K163028
Trade/Device Name: Medline ReNewal Reprocessed Stryker External Fixation Devices Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JEC Dated: October 28, 2016 Received: October 31, 2016
Dear Brandi Panteleon:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Caroline Rhim -S
for
Mark Melkerson Division Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure: Reprocessed List
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| Part Number | Description | ||
|---|---|---|---|
| 4920-1-010 | Rod to Rod Coupling for 8mm rods or posts | ||
| 4920-1-020 | Pin to Rod Coupling for 4-5mm pins/8mm rods or posts | ||
| 4920-1-030 | Inverted Pin to Rod Coupling for 8mm rods or posts/4-5mm pins | ||
| 4920-1-100 | Tube to Rod Coupling for 20mm tubes/8mm rods or posts | ||
| 4920-2-020 | 5 Hole Pin Clamp for 4/5/6mm pins | ||
| 4920-2-060 | 10-Hole Pin Clamp for 4/5/6mm pins | ||
| 4920-2-080 | Pelvic Clamp for 4/5/6mm pins | ||
| 4920-2-120 | Straight Post 8mm | ||
| 4920-2-140 | 30° Angled Post 8mm | ||
| 4920-2-160 | 90° Angled Post 8mm | ||
| 4920-2-181 | HII THREADED POST W 13mm NUT | ||
| 4920-9-020 | Removable Thumbwheel | ||
| 4940-1-010 | Rod to Rod Coupling for Ø5mm rods or posts | ||
| 4940-1-015 | HII Compact Baltimore Coupling | ||
| 4940-1-020 | Pin to Rod Coupling- Ø5mm rods or posts/Ø3-4mm pins | ||
| 4940-1-058 | Rod to Rod Coupling-Ø8mm rods, posts/Ø5mm rods, posts | ||
| 4940-1-100 | Tube to Rod Coupling - Ø15mm tube/Ø5mm rods or posts | ||
| 4940-2-020 | Hoffmann 2 Compact Pin Clamp 4 hole Pin Clamp-Ø3 and Ø4mm pins | ||
| 4940-2-120 | Straight Post Ø5mm | ||
| 4940-2-140 | 30° Angled Post Ø5mm | ||
| 4940-2-200 | Peri-Articular Pin Clamp for Ø3mm pins | ||
| 4960-1-010 | Micro Rod to Rod Coupling 3mm/3mm | ||
| 4960-1-020 | Micro Pin to Rod Coupling 1.65mm-2mm/3mm | ||
| 4960-1-060 | Micro Rod to Rod Coupling 5mm/3mm | ||
| 4960-2-020 | Micro Multi-Pin Clamp | ||
| 4960-2-030 | 90° Micro Multi-Pin Clamp | ||
| 4960-3-020 | HII Micro Lengthener Pin Clamp | ||
| 4960-3-030 | HII Micro Lengthener Thumbwheel | ||
| 5029-1-611 | Ball Joint 5 Hole Double Parallel | ||
| 5029-8-805 | Carbon Connecting Rod 8mm x 65mm | ||
| 5029-8-810 | Carbon Connecting Rod 8mm x 100mm | ||
| 5029-8-815 | Carbon Connecting Rod 8mm x 150mm | ||
| 5029-8-820 | Carbon Connecting Rod 8mm x 200mm | ||
| 5029-8-825 | Carbon Connecting Rod 8mm x 250mm | ||
| 5029-8-830 | Carbon Connecting Rod 8mm x 300mm | ||
| 5029-8-835 | Carbon Connecting Rod 8mm x 350mm | ||
| 5029-8-840 | Carbon Connecting Rod 8mm x 400mm | ||
| 5029-8-845 | Carbon Connecting Rod 8mm x 450mm | ||
| 5029-8-850 | Carbon Connecting Rod 8mm x 500mm | ||
| 5049-5-065 | Stainless Steel Connecting Rod Ø5mm x 65mm | ||
| 5049-5-100 | Stainless Steel Connecting Rod Ø5mm x 100mm | ||
| 5049-5-150 | Stainless Steel Connecting Rod Ø5mm x 150mm | ||
| 5049-5-200 | Stainless Steel Connecting Rod Ø5mm x 200mm | ||
| 5049-5-250 | Stainless Steel Connecting Rod Ø5mm x 250mm | ||
| 5049-5-300 | Stainless Steel Connecting Rod Ø5mm x 300mm | ||
| 5049-5-505 | Carbon Connecting Rod Ø5mm x 65mm | ||
| 5049-5-510 | Carbon Connecting Rod Ø5mm x 100mm | ||
| 5049-5-515 | Carbon Connecting Rod Ø5mm x 150mm | ||
| 5049-5-520 | Carbon Connecting Rod Ø5mm x 200mm | ||
| 5049-5-525 | Carbon Connecting Rod Ø5mm x 250mm | ||
| 5049-5-530 | Carbon Connecting Rod Ø5mm x 300mm | ||
| 5049-7-018 | Semi Circular Curved Rod-Stainless Steel Ø5mm x 111mm | ||
| 5049-7-020 | Semi Circular Curved Rod-Stainless Steel Ø5mm x 146mm | ||
| 5079-5-030 | Stainless Steel Connecting Rod 3mm x 30mm | ||
| 5079-5-040 | Stainless Steel Connecting Rod 3mm x 40mm | ||
| 5079-5-050 | Stainless Steel Connecting Rod 3mm x 50mm | ||
| 5079-5-060 | Stainless Steel Connecting Rod 3mm x 600mm | ||
| 5079-5-070 | Connecting Rod 3mm x 70mm | ||
| 5079-5-090 | 5079-5-120 | Stainless Steel Connecting Rod 3mm x 90mm | Stainless Steel Connecting Rod 3mm x 120mm |
| 5079-5-150 | Stainless Steel Connecting Rod 3mm x 150mm | ||
| 5079-5-180 | Connecting Rod 3mm x 180mm | ||
| 5079-5-250 | Connecting Rod 3mm x 250mm | ||
| 5079-5-300 | Connecting Rod 3mm x 300mm | ||
| 5079-6-030 | Carbon Connecting Rod 3mm x 30mm | ||
| 5079-6-040 | Carbon Connecting Rod 3mm x 40mm | ||
| 5079-6-050 | Carbon Connecting Rod 3mm x 50mm | ||
| 5079-6-060 | Carbon Connecting Rod 3mm x 60mm | ||
| 5079-6-090 | Carbon Connecting Rod 3mm x 90mm | ||
| 5079-6-120 | Carbon Connecting Rod 3mm x 120mm | ||
| 5079-6-150 | Carbon Connecting Rod 3mm x 150mm |
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| Part Number | Description |
|---|---|
| 4921-1-010 | MR conditional 8mm Rods or Posts, Rod to Rod Coupling (Gold Hardware) |
| 4921-1-020 | MR conditional Pin to Rod Coupling for Ø4-5mm pins/Ø8mm rods or posts (Gold Hardware) |
| 4921-1-030 | MR conditional Inverted Pin to Rod Coupling for Ø8mm rods or posts/Ø4-5mm pins (Gold Hardware) |
| 4921-1-100 | MR conditional Tube to Rod Coupling for Ø20mm tubes/Ø8mm rods or posts (Gold Hardware) |
| 4921-2-020 | MR conditional 5-Hole Pin Clamp for Ø4, Ø5, and Ø6mm pins (Gold Hardware) |
| 4921-2-060 | MR conditional 10-Hole Pin Clamp for Ø4, Ø5, and Ø6mm pins (Gold Hardware) |
| 4921-2-080 | MR conditional Pelvic Clamp for Ø4, Ø5, and Ø6mm pins (Gold Hardware) |
| 4921-2-120 | MR conditional Straight Post Ø8mm (Gold Tip) |
| 4921-2-140 | MR conditional 30° Angled Post Ø8mm (Gold Tip) |
| 4941-1-010 | MR conditional rod to Rod Coupling for Ø5mm rods or posts |
| 4941-1-020 | MR conditional Pin to Rod Coupling for Ø5mm rods or posts/Ø3-4mm pins |
| 4941-1-058 | MR conditional Rod to Rod Coupling for Ø8mm rods or posts/Ø5mm rods or posts |
| 4941-1-100 | MR conditional Tube to Rod Coupling for Ø15mm tube/Ø5mm rods or posts |
| 4941-2-120 | MR conditional 30° Angled Post Ø5mm |
| 4941-2-140 | MR conditional 4941-2-140 30° Angled Post Ø5mm |
| 4941-2-200 | MR conditional Peri-Articular Pin Clamp for Ø3mm pins |
| 5028-7-030 | MR conditional Semi-Circular Carbon Rod 174mm (L) |
| 5028-8-065 | MR conditional Carbon Connecting Rod 65mm Ø8mm (Yellow) |
| 5028-8-100 | MR conditional Carbon Connecting Rod 100mm Ø8mm (Yellow) |
| 5028-8-150 | MR conditional Carbon Connecting Rod 150mm Ø8mm (Yellow) |
| 5028-8-200 | MR conditional Carbon Connecting Rod 200mm Ø8mm (Yellow) |
| 5028-8-250 | MR conditional Carbon Connecting Rod 250mm Ø8mm (Yellow) |
| 5028-8-300 | MR conditional Carbon Connecting Rod 300mm Ø8mm (Yellow) |
| 5028-8-350 | MR conditional Carbon Connecting Rod 350mm Ø8mm (Yellow) |
| 5028-8-400 | MR conditional Carbon Connecting Rod 400mm Ø8mm (Yellow) |
| 5028-8-450 | MR conditional Carbon Connecting Rod 450mm Ø8mm (Yellow) |
| 5028-8-500 | MR conditional Carbon Connecting Rod 500mm Ø8mm (Yellow) |
| 5048-5-065 | MR conditional Carbon Connecting Rod 65mm Ø5mm (Yellow) |
| 5048-5-100 | MR conditional Carbon Connecting Rod 100mm Ø5mm (Yellow) |
| 5048-5-150 | MR conditional Carbon Connecting Rod 150mm Ø5mm (Yellow) |
| 5048-5-200 | MR conditional Carbon Connecting Rod 200mm Ø5mm (Yellow) |
| 5048-5-250 | MR conditional Carbon Connecting Rod 250mm Ø5mm (Yellow) |
| 5048-5-300 | MR conditional Carbon Connecting Rod 300mm Ø5mm (Yellow) |
| 4921-2-020 | AHS MR conditional 5 HOLE PIN CLAMP |
| 4921-2-160 | MR conditional 90 DEGREE POST |
| 4941-2-020 | 4 hole pin clamp for Ø3 and Ø4mm pins |
| Hoffmann III MR Conditional (1.5 T) | |
| Part Number | Description |
| 4922-1-010 | Delta Coupling, Rod-to-Rod or Pin-to-Rod, Ø5/8/11mm Rods and Ø5mm Apex Pins |
| 4922-1-020 | Delta Coupling, Pin-to-Rod, Ø5/8/11mm Rods and Ø4/5/6mm Apex Pins |
| 4922-1-030 | Delta Coupling, Pin-to-Rod, inverted, Ø5/8/11mm Rods and Ø4/5/6mm Apex Pins |
| 4922-2-020 | 5-Hole Pin Clamp |
| 4922-2-120 | Straight Post Ø11mm |
| 4922-2-140 | 30° Angled Post Ø11mm |
| 4922-2-160 | 90° Angled Post Ø11mm |
| 4922-2-220 | 5-Hole Pin Clamp with two Ø11mm Straight Posts |
| 4922-2-240 | 5-Hole Pin Clamp with two Ø11mm 30° Angled Posts |
| 4922-2-320 | 5-Hole Pin Clamp with one Ø11mm Straight Post |
| 4922-2-340 | 5-Hole Pin Clamp with one Ø11mm 30° Angled Post |
| 4922-8-100 | Ø11mm Vectran coated Carbon Connecting Rods 100mm |
| 4922-8-150 | Ø11mm Vectran coated Carbon Connecting Rods 150mm |
| 4922-8-200 | Ø11mm Vectran coated Carbon Connecting Rods 200mm |
| 4922-8-250 | Ø11mm Vectran coated Carbon Connecting Rods 250mm |
| 4922-8-300 | Ø11mm Vectran coated Carbon Connecting Rods 300mm |
| 4922-8-350 | Ø11mm Vectran coated Carbon Connecting Rods 350mm |
| 4922-8-400 | Ø11mm Vectran coated Carbon Connecting Rods 400mm |
| 4922-8-450 | Ø11mm Vectran coated Carbon Connecting Rods 450mm |
| 4922-8-500 | Ø11mm Vectran coated Carbon Connecting Rods 500mm |
| 4922-8-550 | Ø11mm Vectran coated Carbon Connecting Rods 550mm |
| 4922-8-600 | Ø11mm Vectran coated Carbon Connecting Rods 600mm |
| 4922-8-650 | Ø11mm Vectran coated Carbon Connecting Rods 650mm |
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Indications for Use
Device Name
Medline ReNewal Reprocessed Stryker External Fixation Devices
Indications for Use (Describe)
The Medline ReNewal Reprocessed Stryker External Fixation Devices are external fixation frame components for use with components of the Hoffmann 3 MR Conditional. Hoffmann II MR Conditional. Hoffmann II Compact MR Conditional and Hoffmann II Compact external fixation systems. They are intended to provide stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts or other mean of internal fixations for use of external fixation devices include:
- · bone fracture fixation;
- · osteotomy:
- · arthrodesis:
- · correction of deformity; revision procedure where other treatments or devices have been unsuccessful; and
- · bone reconstruction procedures.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
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Image /page/6/Picture/1 description: The image shows the logo for Medline Renewal. The Medline logo is on the left, and it features the word "MEDLINE" in blue, with a blue star-like symbol below it. To the right of the Medline logo is the word "Renewal" in large, bold letters, with "Re" in green and "newal" in blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in a smaller, lighter font.
510(k) Summary K163028
| Submitter/Owner | Surgical Instrument Service and Saving Inc. dba Medline ReNewal2747 SW 6th St.Redmond, OR 97756 | |
|---|---|---|
| Contact Name | Brandi PanteleonDirector, Quality Assurance and Regulatory AffairsP: 541-516-4180F: 541-923-3375E: bpanteleon@medline.com | |
| Prepared by | Stephanie Boyle MaysRegulatory Affairs Specialist, Regulatory AffairsP: 541-516-4205F: 541-923-3375E:smays@medline.com | |
| Date Prepared | October 28, 2016 | |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed Stryker ExternalFixation DevicesCommon Name: External Fixation Devices, Fixation Appliance,single/multiple component (component) | |
| Classification | Classification: Class IIClassification Name: Single/multiple component metallic bone fixationappliances and accessories and smooth or threaded metallic bone fixationfastener.Regulation Number/Product Code: 888.3030/JEC (subsequent code LXT);888.3040/JEC; and 888.3030/KTT | |
| PredicateDevice | K102885 Stryker Hoffman II External Fixation System Line Extension Model4920-1-010, 4920-1-020; 4920-1-030, 4920-1-100, Hoffmann II EX | |
| ReferenceDevice 1 | K952730 Howmedica Hoffmann II External Fixation System | |
| ReferenceDevice 2 | K122284 Stryker Hoffmann 3 Modular External Fixation System | |
| DeviceDescription | The Medline ReNewal Reprocessed Stryker External Fixation Devices areintended to provide temporary stabilization of open and/or unstablefractures where soft tissue injury may preclude the use of other fracturetreatments. Additionally, the devices may be used for elective orthopedicinterventions such as limb lengthening. Devices in the scope of thisdocument include various rods and clamps/connectors that are assembledexternal to the operative or injury focus and will not be in direct patientcontact. | |
| Statement ofIntended Use | The Medline ReNewal Reprocessed Stryker External Fixation Devices arecomponents in an external fixation system that is used to providestabilization of open and/or unstable fractures and where soft tissue injurymay preclude the use of other fracture treatments such as IM rods, casts orother means of fixation. | |
| Indications | The Medline ReNewal Reprocessed Stryker External Fixation Devices are external fixation frame components for use with components of the Hoffman 3 MR Conditional, Hoffmann II MR Conditional, Hoffmann II, Hoffmann II Compact MR Conditional and Hoffmann II Compact external fixation systems. They are intended to provide stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts or other mean of internal fixation The indications for use of external fixation devices include:• bone fracture fixation;• osteotomy;• arthrodesis;• correction of deformity; revision procedure where other treatments or devices have been unsuccessful; and• bone reconstruction procedures. | |
| TechnologicalCharacteristics | The Medline ReNewal Reprocessed Stryker External Fixation Devices are rods, couplings, connectors, clamps, posts and accessories that, when combined with other components, are used to build external skeletal constructs for the devices intended use. The proposed device is a reprocessed version of the predicate device and the technological characteristics of these devices are substantially equivalent. | |
| PerformanceTesting | The functional characteristics of the subject device have been evaluated and have been determined to be substantially equivalent to the predicate device based on the following tests:• Functional performance studies:◦ simulated use and artificial soiling; and◦ structural integrity;◦ carbon rod stiffness per the 4-point bend test (pre-conditioning);◦ cyclical axial compression and tension bending test;◦ carbon rod stiffness per the 4-point bend test (post conditioning); and◦ disassembly and reassembly (pre-and post-sterilization).• Cleaning:◦ visual inspection;◦ cleaning efficacy (residual protein and residual carbohydrate). | |
| OEMModel | Description | |
| Hoffmann II | ||
| Device Models | 4920-1-010 | Rod to Rod Coupling for 8mm rods or posts |
| 4920-1-020 | Pin to Rod Coupling for 4-5mm pins/8mm rods or posts | |
| 4920-1-030 | Inverted Pin to Rod Coupling for 8mm rods or posts/4-5mm pins | |
| 4920-1-100 | Tube to Rod Coupling for 20mm tubes/8mm rods or posts | |
| 4920-2-020 | 5 Hole Pin Clamp for 4/5/6mm pins | |
| 4920-2-060 | 10-Hole Pin Clamp for 4/5/6mm pins | |
| 4920-2-080 | Pelvic Clamp for 4/5/6mm pins | |
| 4920-2-120 | Straight Post 8mm | |
| 4920-2-140 | 30° Angled Post 8mm | |
| OEMModel | Description | |
| Hoffman II continued | ||
| 4920-2-181 | HII THREADED POST W 13mm NUT | |
| 4920-9-020 | Removable Thumbwheel | |
| 4940-1-010 | Rod to Rod Coupling for Ø5mm rods or posts | |
| 4940-1-015 | HII Compact Baltimore Coupling | |
| 4940-1-020 | Pin to Rod Coupling- Ø5mm rods or posts/Ø3-4mm pins | |
| 4940-1-058 | Rod to Rod Coupling-Ø8mm rods, posts/Ø5mm rods, posts | |
| 4940-1-100 | Tube to Rod Coupling - Ø15mm tube/Ø5mm rods or posts | |
| 4940-2-020 | Hoffmann 2 Compact Pin Clamp 4 hole Pin Clamp-Ø3 andØ4mm pins | |
| 4940-2-120 | Straight Post Ø5mm | |
| 4940-2-140 | 30° Angled Post Ø5mm | |
| 4940-2-200 | Peri-Articular Pin Clamp for Ø3mm pins | |
| 4960-1-010 | Micro Rod to Rod Coupling 3mm/3mm | |
| 4960-1-020 | Micro Pin to Rod Coupling 1.65mm-2mm/3mm | |
| 4960-1-060 | Micro Rod to Rod Coupling 5mm/3mm | |
| 4960-2-020 | Micro Multi-Pin Clamp | |
| 4960-2-030 | 90° Micro Multi-Pin Clamp | |
| 4960-3-020 | HII Micro Lengthener Pin Clamp | |
| 4960-3-030 | HII Micro Lengthener Thumbwheel | |
| 5029-1-611 | Ball Joint 5 Hole Double Parallel | |
| 5029-8-805 | Carbon Connecting Rod 8mm x 65mm | |
| 5029-8-810 | Carbon Connecting Rod 8mm x 100mm | |
| 5029-8-815 | Carbon Connecting Rod 8mm x 150mm | |
| 5029-8-820 | Carbon Connecting Rod 8mm x 200mm | |
| 5029-8-825 | Carbon Connecting Rod 8mm x 250mm | |
| 5029-8-830 | Carbon Connecting Rod 8mm x 300mm | |
| 5029-8-835 | Carbon Connecting Rod 8mm x 350mm | |
| 5029-8-840 | Carbon Connecting Rod 8mm x 400mm | |
| 5029-8-845 | Carbon Connecting Rod 8mm x 450mm | |
| 5029-8-850 | Carbon Connecting Rod 8mm x 500mm | |
| 5049-5-065 | Stainless Steel Connecting Rod Ø5mm x 65mm | |
| 5049-5-100 | Stainless Steel Connecting Rod Ø5mm x 100mm | |
| 5049-5-150 | Stainless Steel Connecting Rod Ø5mm x 150mm | |
| 5049-5-200 | Stainless Steel Connecting Rod Ø5mm x 200mm | |
| 5049-5-250 | Stainless Steel Connecting Rod Ø5mm x 250mm | |
| 5049-5-300 | Stainless Steel Connecting Rod Ø5mm x 300mm | |
| 5049-5-505 | Carbon Connecting Rod Ø5mm x 65mm | |
| 5049-5-510 | Carbon Connecting Rod Ø5mm x 100mm | |
| 5049-5-515 | Carbon Connecting Rod Ø5mm x 150mm | |
| 5049-5-520 | Carbon Connecting Rod Ø5mm x 200mm | |
| 5049-5-525 | Carbon Connecting Rod Ø5mm x 250mm | |
| 5049-5-530 | Carbon Connecting Rod Ø5mm x 300mm | |
| 5049-7-018 | Semi Circular Curved Rod-Stainless Steel Ø5mm x 111mm | |
| OEMModel | Description | |
| Hoffman II continued | ||
| 5079-5-030 | Stainless Steel Connecting Rod 3mm x 30mm | |
| 5079-5-040 | Stainless Steel Connecting Rod 3mm x 40mm | |
| 5079-5-050 | Stainless Steel Connecting Rod 3mm x 50mm | |
| 5079-5-060 | Stainless Steel Connecting Rod 3mm x 600mm | |
| 5079-5-070 | Connecting Rod 3mm x 70mm | |
| 5079-5-090 | Stainless Steel Connecting Rod 3mm x 90mm | |
| 5079-5-120 | Stainless Steel Connecting Rod 3mm x 120mm | |
| 5079-5-150 | Stainless Steel Connecting Rod 3mm x 150mm | |
| 5079-5-180 | Connecting Rod 3mm x 180mm | |
| 5079-5-250 | Connecting Rod 3mm x 250mm | |
| 5079-5-300 | Connecting Rod 3mm x 300mm | |
| 5079-6-030 | Carbon Connecting Rod 3mm x 30mm | |
| 5079-6-040 | Carbon Connecting Rod 3mm x 40mm | |
| 5079-6-050 | Carbon Connecting Rod 3mm x 50mm | |
| 5079-6-060 | Carbon Connecting Rod 3mm x 60mm | |
| 5079-6-090 | Carbon Connecting Rod 3mm x 90mm | |
| 5079-6-120 | Carbon Connecting Rod 3mm x 120mm | |
| 5079-6-150 | Carbon Connecting Rod 3mm x 150mm | |
| Hoffmann II MR Conditional (3.0 T) | ||
| 4921-1-010 | MR conditional 8mm Rods or Posts, Rod to Rod Coupling(Gold Hardware) | |
| 4921-1-020 | MR conditional Pin to Rod Coupling for Ø4-5mmpins/Ø8mm rods or posts (Gold Hardware) | |
| 4921-1-030 | MR conditional Inverted Pin to Rod Coupling for Ø8mmrods or posts/Ø4-5mm pins (Gold Hardware) | |
| 4921-1-100 | MR conditional Tube to Rod Coupling for Ø20mmtubes/Ø8mm rods or posts (Gold Hardware) | |
| 4921-2-020 | MR conditional 5-Hole Pin Clamp for Ø4, Ø5, and Ø6mmpins (Gold Hardware) | |
| 4921-2-060 | MR conditional 10-Hole Pin Clamp for Ø4, Ø5, and Ø6mmpins (Gold Hardware) | |
| 4921-2-080 | MR conditional Pelvic Clamp for Ø4, Ø5, and Ø6mm pins(Gold Hardware) | |
| 4921-2-120 | MR conditional Straight Post Ø8mm (Gold Tip) | |
| 4921-2-140 | MR conditional 30° Angled Post Ø8mm (Gold Tip) | |
| 4941-1-010 | MR conditional rod to Rod Coupling for Ø5mm rods orposts | |
| 4941-1-020 | MR conditional Pin to Rod Coupling for Ø5mm rods orposts/Ø3-4mm pins | |
| 4941-1-058 | MR conditional Rod to Rod Coupling for Ø8mm rods orposts/Ø5mm rods or posts | |
| 4941-1-100 | MR conditional Tube to Rod Coupling for Ø15mmtube/Ø5mm rods or posts | |
| 4941-2-120 | MR conditional 30° Angled Post Ø5mm | |
| 4941-2-140 | MR conditional 4941-2-140 30° Angled Post Ø5mm | |
| 4941-2-200 | MR conditional Peri-Articular Pin Clamp for Ø3mm pins | |
| OEMModel | Description | |
| Hoffmann II MR Conditional (3.0 T) | ||
| 5028-7-030 | MR conditional Semi-Circular Carbon Rod 174mm (L) | |
| 5028-8-065 | MR conditional Carbon Connecting Rod 65mm Ø8mm(Yellow) | |
| 5028-8-100 | MR conditional Carbon Connecting Rod 100mm Ø8mm(Yellow) | |
| 5028-8-150 | MR conditional Carbon Connecting Rod 150mm Ø8mm(Yellow) | |
| 5028-8-200 | MR conditional Carbon Connecting Rod 200mm Ø8mm(Yellow) | |
| 5028-8-250 | MR conditional Carbon Connecting Rod 250mm Ø8mm(Yellow) | |
| 5028-8-300 | MR conditional Carbon Connecting Rod 300mm Ø8mm(Yellow) | |
| 5028-8-350 | MR conditional Carbon Connecting Rod 350mm Ø8mm(Yellow) | |
| 5028-8-400 | MR conditional Carbon Connecting Rod 400mm Ø8mm(Yellow) | |
| 5028-8-450 | MR conditional Carbon Connecting Rod 450mm Ø8mm(Yellow) | |
| 5028-8-500 | MR conditional Carbon Connecting Rod 500mm Ø8mm(Yellow) | |
| 5048-5-065 | MR conditional Carbon Connecting Rod 65mm Ø5mm(Yellow) | |
| 5048-5-100 | MR conditional Carbon Connecting Rod 100mm Ø5mm(Yellow) | |
| 5048-5-150 | MR conditional Carbon Connecting Rod 150mm Ø5mm(Yellow) | |
| 5048-5-200 | MR conditional Carbon Connecting Rod 200mm Ø5mm(Yellow) | |
| 5048-5-250 | MR conditional Carbon Connecting Rod 250mm Ø5mm(Yellow) | |
| 5048-5-300 | MR conditional Carbon Connecting Rod 300mm Ø5mm(Yellow) | |
| 4921-2-020AHS | MR conditional 5 HOLE PIN CLAMP | |
| 4921-2-160 | MR conditional 90 DEGREE POST | |
| 4941-2-020 | 4 hole pin clamp for Ø3 and Ø4mm pins | |
| Hoffman 3 MR conditional (1.5 T) | ||
| 4922-1-010 | Delta Coupling, Rod-to-Rod or Pin-to-Rod, Ø5/8/11mmRods and Ø5mm Apex Pins | |
| 4922-1-020 | Delta Coupling, Pin-to-Rod, Ø5/8/11mm Rods andØ4/5/6mm Apex Pins | |
| 4922-1-030 | Delta Coupling, Pin-to-Rod, inverted, Ø5/8/11mm Rods andØ4/5/6mm Apex Pins | |
| 4922-2-020 | 5-Hole Pin Clamp | |
| 4922-2-120 | Straight Post Ø11mm | |
| OEM Model | Description | |
| Hoffman III MR conditional (1.5 T) | ||
| 4922-2-140 | 30° Angled Post Ø11mm | |
| 4922-2-160 | 90° Angled Post Ø11mm | |
| 4922-2-220 | 5-Hole Pin Clamp with two Ø11mm Straight Posts | |
| 4922-2-240 | 5-Hole Pin Clamp with two Ø11mm 30o Angled Posts | |
| 4922-2-320 | 5-Hole Pin Clamp with one Ø11mm Straight Post | |
| 4922-2-340 | 5-Hole Pin Clamp with one Ø11mm 30o Angled Post | |
| 4922-8-100 | Ø11mm Vectran coated Carbon Connecting Rods 100mm | |
| 4922-8-150 | Ø11mm Vectran coated Carbon Connecting Rods 150mm | |
| 4922-8-200 | Ø11mm Vectran coated Carbon Connecting Rods 200mm | |
| 4922-8-250 | Ø11mm Vectran coated Carbon Connecting Rods 250mm | |
| 4922-8-300 | Ø11mm Vectran coated Carbon Connecting Rods 300mm | |
| 4922-8-350 | Ø11mm Vectran coated Carbon Connecting Rods 350mm | |
| 4922-8-400 | Ø11mm Vectran coated Carbon Connecting Rods 400mm | |
| 4922-8-450 | Ø11mm Vectran coated Carbon Connecting Rods 450mm | |
| 4922-8-500 | Ø11mm Vectran coated Carbon Connecting Rods 500mm | |
| 4922-8-550 | Ø11mm Vectran coated Carbon Connecting Rods 550mm | |
| 4922-8-600 | Ø11mm Vectran coated Carbon Connecting Rods 600mm | |
| 4922-8-650 | Ø11mm Vectran coated Carbon Connecting Rods 650mm | |
| a | OEM = original equipment manufacturer. |
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Image /page/7/Picture/1 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is in green and blue, and the text "Full Circle Reprocessing" is below the Renewal logo.
90° Angled Post 8mm
4920-2-160
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Image /page/8/Picture/1 description: The image contains the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is green and blue, and the text below it says "Full Circle Reprocessing".
Device Models continued
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Image /page/9/Picture/1 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters next to it. The Renewal logo is in two colors, with "Re" in green and "Newal" in blue. Below Renewal, the words "Full Circle Reprocessing" are written in a smaller font.
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Image /page/10/Picture/1 description: The image shows the Medline Renewal logo. The word "Medline" is in blue and is accompanied by a blue star-like symbol. To the right of the Medline logo is the word "Renewal" in green and blue, with "Re" in green and "newal" in blue. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in a smaller font.
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Image /page/11/Picture/1 description: The image contains the Medline Renewal logo. The word "Renewal" is written in a combination of green and blue colors, with "Re" in green and "newal" in blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in a smaller font size and in blue. To the left of the word "Renewal" is the Medline logo, which consists of the word "MEDLINE" in blue with a stylized blue star below it.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.