(85 days)
Not Found
No
The device description and performance studies focus on the mechanical function and reprocessing of surgical shavers and burs, with no mention of AI or ML capabilities.
Yes
The device is used to resect soft tissue and bone, which are therapeutic actions.
No
The device is described as shavers and burs intended for resection of soft tissue and bone in surgical procedures. It is a surgical tool, not a diagnostic device.
No
The device description clearly outlines physical components (metal shafts, lubricants, polymer hubs, blades, burs) and their mechanical function (cutting, grinding, rotation). There is no mention of software as a component or primary function of the device itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are used for surgical procedures to resect soft tissue and bone within the body. This is a direct surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the mechanical function of the shavers and burs for cutting and grinding tissue and bone during surgery. This aligns with surgical tools, not diagnostic devices.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a surgical instrument used during a procedure, not a tool for diagnosing a condition before or after a procedure based on in vitro analysis.
N/A
Intended Use / Indications for Use
The Reprocessed Linvatec shavers and burs are intended for use with the Linvatec Integrated Drive/Pump System to perform resection of soft tissue and bone. The fields of application include Otolaryngology, Neurological Surgical, Orthopedic, and Spinal surgical procedures.
The Reprocessed Smith & Nephew shavers and burs are intended for use with the Smith & Nephew DYONICS Power II Shaver System control unit, for resection of soft and osseous tissues including but not limited to, use in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure.
The Reprocessed Styker Shavers and Burs are intended for use with the Styker Total Performance System Shaver handpiece and the Stryker Total Performance System by surgeons in the following orthopedic joints:
Knee
-
Shoulder
-
Ankle
-
Elbow
-
Wrist
-
Hip
-
Temporamandibular
The Reprocessed Styker Shavers and Burs will be used to resect tissue and bur bone. Examples of uses of the product would include resection of torn knee cartilage, subacromial decompression and resection of synovial tissue in other joints.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
The Reprocessed Shavers and Burs are intended to be used for arthroscopic and laparoscopic surgical techniques. Shavers have sharp rotating inner blades housed in an outer shaft designed to cut tissue. Burs have an abrasive wearing surface that rotate in an outer sheath to grind down bone. The housing has a window cut out on one side of the distal end, allowing the bur to cut one part of the intended anatomy, while the adjacent one is still protected by the housing on the opposite side of the abrader, bur or blade.
There are various configurations of diameter, length, and cutting or grinding surfaces. The materials of construction are generally: metal shafts, lubricants (between the inner and outer components to reduce friction and heat), and polymer hubs bonded to the shafts. The polymer hub connects to a user-supplied motorized hand piece, which drives the internal abrader, bur or blade inside the outer housing. The handpiece provides suction to remove tissue which has been cut during the surgical procedure.
There are 39 Stryker shavers and 33 Stryker burs included in this submission. The Stryker shavers and burs are used with the Total Performance System Shaver handpiece is made of a motor housing with a coupling mechanism to secure the shavers/burs to the handpiece. The Stryker shavers and burs are intended to be used to resect tissue and bur bone in orthopedic joints such as the knee, shoulder, ankle, elbow, wrist, hip, etc.
There are 31 Smith & Nephew shavers and 32 Smith & Nephew burs included in this submission. The Smith & Nephew shavers and burs are intended to be used with the Smith & Nephew DYONICS Power II Shaver System control unit. This system is compatible with DYONICS POWER handpieces. It can be used in large or small joint cavities or in sinus surgery.
There are 94 ConMed/Linvatec shavers and 26 ConMed/Linvatec burs included in this submission. The Linvatec shavers and burs are intended to be used with the Linvatec Integrated Drive/Pump system. The system has three different handpieces that ca be used for otolaryngology, neurological surgical, orthopedic, and spinal procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Otolaryngology, Neurological Surgical, Orthopedic, Spinal, large articular cavities, small articular cavities, Functional Endoscopic Sinus Surgery (FESS), Knee, Shoulder, Ankle, Elbow, Wrist, Hip, Temporamandibular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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)
Side by side testing ensured that the shavers and burs performed equivalently to the same device new from the OEM. Cleaning validations ensured that the devices are reprocessed and cleaned to the condition of a new OEM device. Therefore, based on a comparison of technological characteristics, indications for use, and performance comparison data, it can be concluded that the proposed Reprocessed Shavers/Burs are substantially equivalent to the OEM predicate device.
Performance Testing:
- Functional Testing
- Performance testing comparison against new OEM device (sharpness and bending)
- Drop Testing comparison against new OEM device
- Product Stability
- Shelf Life Testing 1-Year Accelerated Aging
Biocompatibility Testing:
- Cytotoxicity
- Irritation
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Sensitization
Cleaning Validation:
- Residual Protein and Carbohydrates
- Visual Inspection
- Cleaning Performance Qualification
Sterilization and Packaging:
- EtO Sterilization Validation
- EtO Residuals Testing
- Simulated Shipment Testing
Electrical Safety and EMC Testing:
Electrical safety and EMC testing were not applicable.
Animal Testing:
Animal performance testing was not required to demonstrate safety and effectiveness.
Clinical Testing:
Clinical testing was not required to demonstrate the safety and effectiveness of the Reprocessed Shavers/Burs. Substantial equivalence is based upon benchtop performance testing.
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.
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
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
Image /page/0/Picture/2 description: The image is a logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an image of three faces in profile, one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 4, 2017
Renovo. Inc. % Mr. Robert Packard Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, Vermont 05738
Re: K172092
Trade/Device Name: Reprocessed Shavers/Burs Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: September 21, 2017 Received: September 21, 2017
Dear Mr. Packard:
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 Actinclude 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 device
1
related 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.
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 (DICE) 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 (DICE) 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, Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172092
Device Name Reprocessed Linvatec Shavers/Burs
Indications for Use (Describe)
The Reprocessed Linvatec shavers and burs are intended for use with the Linvatec Integrated Drive/Pump System to perform resection of soft tissue and bone. The fields of application include Otolaryngology, Neurological Surgical, Orthopedic, and Spinal surgical 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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3
Reprocessed Single-Use Linvatec Shavers & Burs Device Models Subject to Clearance (120 Linvatec devices in total)
| OEM Model # | Description | Diameter | Picture | OEM |
|---|---|---|---|---|
| DPS-C002 | Large Hub Shaver Blades, | |||
| UltraGator | 4.2mm | Image: Shaver blade | Conmed/Linvatec | |
| DPS-C003 | Large Hub Shaver Blades, | |||
| UltraGator | 5.5mm | Image: Shaver blade | Conmed/Linvatec | |
| DPS-C010 | Large Hub Shaver Blades, UltraFRR | 4.2mm | Image: Shaver blade | Conmed/Linvatec |
| DPS-C011 | Large Hub Shaver Blades, UltraFRR | 5.5mm | Image: Shaver blade | Conmed/Linvatec |
| DPS-C005 | Large Hub Shaver Blades, | |||
| UltraTiger | 4.2mm | Image: Shaver blade | Conmed/Linvatec | |
| 9399A | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Great White | ||||
| Blade | 3.5mm | Image: Shaver blade | Conmed/Linvatec | |
| 9299A | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Great White | ||||
| Blade | 4.2mm | Image: Shaver blade | Conmed/Linvatec | |
| 9297A | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Great White | ||||
| Blade | 4.8mm | Image: Shaver blade | Conmed/Linvatec | |
| 9599A | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Great White | ||||
| Blade | 5.5mm | Image: Shaver blade | Conmed/Linvatec | |
| EL9299 | Large Hub Shaver Blades, Large | |||
| Hub, Merlin, Shaver, Great White | ||||
| Blade | 4.2mm | Image: Shaver blade | Conmed/Linvatec | |
| 35ULT-ST-ZZ | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Ultracut | 3.5mm | Image: Shaver blade | Conmed/Linvatec | |
| C9405 | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Ultracut | 4.2mm | Image: Shaver blade | Conmed/Linvatec | |
| C9415 | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Ultracut | 5.5mm | Image: Shaver blade | Conmed/Linvatec | |
| EL9405 | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Ultracut | 4.2mm | Image: Shaver blade | Conmed/Linvatec | |
| 9298A | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Mako Blade | 4.2mm | Image: Shaver blade | Conmed/Linvatec | |
| C9299A | Large Hub Shaver Blades, Pre-Bent | |||
| 15°, Great White Blade | 4.2mm | Image: Shaver blade | Conmed/Linvatec | |
| C9248 | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Full-Radius | ||||
| Resector | 3.5mm | Image: Shaver blade | Conmed/Linvatec | |
| 9247A | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Full-Radius | ||||
| Resector | 4.2mm | Image: Shaver blade | Conmed/Linvatec | |
| C9245 | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Full-Radius | ||||
| Resector | 4.8mm | Image: Shaver blade | Conmed/Linvatec | |
| 9246A | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Full-Radius | ||||
| Resector | 5.5mm | Image: Shaver blade | Conmed/Linvatec | |
| 42FRR-RA-ZZ | Large Hub Shaver Blades, Large | |||
| Hub, ReAct, Shaver, Great White | ||||
| Blade | 3.5mm | Image: blade | Conmed/Linvatec | |
| 42FRR-RA-ZZ | Large Hub Shaver Blades, Large | |||
| Hub, ReAct, Shaver, Great White | ||||
| Blade | 4.2mm | Image: blade | Conmed/Linvatec | |
| C9943A | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Full-Radisu | ||||
| Resector | 2.0mm | Image: blade | Conmed/Linvatec | |
| C9944A | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Full-Radius | ||||
| Resector Blade | 2.0mm | Image: blade | Conmed/Linvatec | |
| C9264 | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Gator Blade | 3.5mm | Image: blade | Conmed/Linvatec | |
| 9263A | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Gator Blade | 4.2mm | Image: blade | Conmed/Linvatec | |
| C9262 | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Gator Blade | 4.8mm | Image: blade | Conmed/Linvatec | |
| 9260A | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Gator Blade | 5.5mm | Image: blade | Conmed/Linvatec | |
| 35GTR-RA-ZZ | Large Hub Shaver Blades, Large | |||
| Hub, ReAct, Shaver, Gator | 3.5mm | Image: blade | Conmed/Linvatec | |
| 42GTR-RA-ZZ | Large Hub Shaver Blades, Large | |||
| Hub, ReAct, Shaver, Gator | 4.2mm | Image: blade | Conmed/Linvatec | |
| EL9263A | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Gator | 4.2mm | Image: blade | Conmed/Linvatec | |
| EL9260A | Large Hub Shaver Blades , Large | |||
| Hub, Sterling, Shaver, Gator | 5.5mm | Image: blade | Conmed/Linvatec | |
| C9960A | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Gator | 2.0mm | Image: blade | Conmed/Linvatec | |
| C9961A | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Gator | 2.9mm | Image: blade | Conmed/Linvatec | |
| C9253 | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Cuda | 3.5mm | Image: blade | Conmed/Linvatec | |
| C9254 | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Cuda | 4.2mm | Image: blade | Conmed/Linvatec | |
| C9258 | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Cuda | 4.8mm | Image: blade | Conmed/Linvatec | |
| C9255 | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Cuda | 5.5mm | Image: blade | Conmed/Linvatec | |
| P9355 | Large Hub Shaver Blades, Large | |||
| Hub, Merlin, Shaver, Cuda | 3.7mm | Image: blade | Conmed/Linvatec | |
| 35CUD-RA-ZZ | Large Hub Shaver Blades, Large | |||
| Hub, ReAct®, Shaver, Cuda | 3.5mm | Image: blade | Conmed/Linvatec | |
| 42CUD-RA-ZZ | Large Hub Shaver Blades, Large | |||
| Hub, ReAct, Shaver, Cuda | 4.2mm | Image: blade | Conmed/Linvatec | |
| C9951A | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Cuda | 2.0mm | Image: blade | Conmed/Linvatec | |
| C9952A | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Cuda | 2.9mm | Image: blade | Conmed/Linvatec | |
| C9240 | Large Hub Shaver Blades, Large | |||
| Hub, Sterling®, Shaver, Tiger® | 3.5mm | Image: blade | Conmed/Linvatec | |
| C9242 | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Tiger | 4.2mm | Image: blade | Conmed/Linvatec | |
| 35TGR-RA-ZZ | Large Hub Shaver Blades, Large | |||
| Hub, ReAct, Shaver, Tiger | 3.5mm | Image: blade | Conmed/Linvatec | |
| 42TGR-RA-ZZ | Large Hub Shaver Blades, Large | |||
| Hub, ReAct, Shaver, Tiger | 4.2mm | Conmed/Linvatec | ||
| C9283 | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, End Cutter | 3.5mm | Image: [C9283] Conmed/Linvatec | ||
| C9284 | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, End Cutter | 4.2mm | Image: [C9284] Conmed/Linvatec | ||
| C9290 | Large Hub Burs and Routers, Large | |||
| Hub, Sterling®, Shaver, Dragon End | ||||
| Cutter | 3.5mm | Image: [C9290] Conmed/Linvatec | ||
| C9291 | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Shaver, Dragon End | ||||
| Cutter | 4.2mm | Image: [C9291] Conmed/Linvatec | ||
| C9292 | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Shaver, Dragon End | ||||
| Cutter | 5.5mm | Image: [C9292] Conmed/Linvatec | ||
| C9760 | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Shaver, Meniscus | ||||
| Cutter | 3.5mm | Image: [C9760] Conmed/Linvatec | ||
| 9761A | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Shaver, Meniscus | ||||
| Cutter | 4.2mm | Image: [9761A] Conmed/Linvatec | ||
| C9762 | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Shaver, Meniscus | ||||
| Cutter | 5.5mm | Image: [C9762] Conmed/Linvatec | ||
| C9274 | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Shaver, Slotted | ||||
| Whisker | 4.2mm | Image: [C9274] Conmed/Linvatec | ||
| C9275 | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Shaver, Slotted | ||||
| Whisker | 5.5mm | Image: [C9275] Conmed/Linvatec | ||
| H9110 | Large Hub Burs and Routers, Large | |||
| Hub, Sterling®, Bur, Spherical | 3.5mm | Image: [H9110] Conmed/Linvatec | ||
| H9111 | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Bur, Spherical | 4.5mm | Image: [H9111] Conmed/Linvatec | ||
| H9112 | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Bur, Spherical | 5.5mm | Image: [H9112] Conmed/Linvatec | ||
| H9112RH | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Bur, Spherical, 20° | ||||
| Reduced Hood | 5.5mm | Image: [H9112RH] Conmed/Linvatec | ||
| EL9111RH | Large Hub Burs and Routers, Large | |||
| Hub, Extended Length, Sterling, | ||||
| Bur, Spherical, 20° Reduced Hood | 4.5mm | Image: [EL9111RH] Conmed/Linvatec | ||
| 55SPH-EL-RH | Large Hub Burs and Routers, Large | |||
| Hub, Extended Length, Sterling, | ||||
| Bur, Spherical 20° Reduced Hood | 5.5mm | Image: [55SPH-EL-RH] Conmed/Linvatec | ||
| C9911A | Large Hub Burs and Routers, Large | |||
| Hub, Small Joint, Sterling, Bur, | ||||
| Spherical | 2.9mm | Image: [C9911A] Conmed/Linvatec | ||
| H9121 | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Bur, Tapered | 4.0mm | Image: [H9121] Conmed/Linvatec | ||
| H9121RH | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Bur, Tapered, 20° | ||||
| Reduced Hood | 4.0mm | Image: [H9121RH] Conmed/Linvatec | ||
| H9101 | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Bur, Oval | 4.0mm | Image: bur | Conmed/Linvatec | |
| 40VAL-ST-FH | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Bur, Oval, Fully | ||||
| Hooded | 4.0mm | Image: bur | Conmed/Linvatec | |
| H9101RH | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Bur, Oval, 20° | ||||
| Reduced Hood | 4.0mm | Image: bur | Conmed/Linvatec | |
| H9101LH | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Bur, Oval, Left Helix | 4.0mm | Image: bur | Conmed/Linvatec | |
| H9103RH | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Bur, Oval, 20º | ||||
| Reduced Hood | 5.0mm | Image: bur | Conmed/Linvatec | |
| H9102 | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Bur, Oval | 6.0mm | Image: bur | Conmed/Linvatec | |
| H9201LH | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Bur, Oval, Left Helix | 6.0mm | Image: bur | Conmed/Linvatec | |
| EL9101 | Large Hub Burs and Routers, Large | |||
| Hub, Extended Length, Sterling, | ||||
| Bur, Oval | 4.0mm | Image: bur | Conmed/Linvatec | |
| 60VAL-EL-RH | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Bur, Oval, 20° | ||||
| Reduced Hood | 6.0mm | Image: bur | Conmed/Linvatec | |
| H9118 | Large Hub Burs and Routers, Large | |||
| Hub, Sterling®, Bur, Cyclone | 4.5mm | Image: bur | Conmed/Linvatec | |
| H9119 | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Bur, Cyclone | 5.5mm | Image: bur | Conmed/Linvatec | |
| H9131 | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Router, Vortex, 5 | ||||
| Flutes, Hooded | 4.5mm | Image: bur | Conmed/Linvatec | |
| H9134 | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Router, Vortex, 5 | ||||
| Flutes, Unhooded | 4.5mm | Image: bur | Conmed/Linvatec | |
| H9132 | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Router, Vortex, 5 | ||||
| Flutes, Hooded | 6.0mm | Image: bur | Conmed/Linvatec | |
| 29VTX-SJ-ZZ | Large Hub Burs and Routers, Large | |||
| Hub, Small Joint, Sterling, Bur, | ||||
| Vortex Router | 2.9mm | Image: bur | Conmed/Linvatec | |
| 35VTX-SJ-ZZ | Large Hub Burs and Routers, Large | |||
| Hub, Small Joint, Sterling, Bur, | ||||
| Vortex Router | 3.5mm | Conmed/Linvatec | ||
| H9133 | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Lighting | 4.5mm | Image: bur | Conmed/Linvatec | |
| M9299A | Micro Hub Blades, Micro Hub, | |||
| Sterling®, Shaver, Great White | 4.2mm | Image: bur | Conmed/Linvatec | |
| M9298A | Micro Hub Blades, Micro Hub, Sterling, Shaver, Mako | 4.2mm | Conmed/Linvatec | |
| C9940 | Micro Hub Blades, Micro Hub, Sterling®, Blade, Full-Radius Resector | 2.0mm | Conmed/Linvatec | |
| C9941 | Micro Hub Blades, Micro Hub, Sterling, Blade, Full-Radius Resector | 2.9mm | Conmed/Linvatec | |
| C9942 | Micro Hub Blades, Micro Hub, Sterling, Blade, Full-Radius Resector | 3.5mm | Conmed/Linvatec | |
| MC9248 | Micro Hub Blades, Micro Hub, Sterling, Blade, Full-Radius Resector | 3.5mm | Conmed/Linvatec | |
| M9247A | Micro Hub Blades, Micro Hub, Sterling, Blade, Full-Radius Resector | 4.2mm | Conmed/Linvatec | |
| C9960 | Micro Hub Blades, Micro Hub, Sterling, Blade, Gator | 2.0mm | Conmed/Linvatec | |
| C9961 | Micro Hub Blades, Micro Hub, Sterling, Blade, Gator | 2.9mm | Conmed/Linvatec | |
| C9962 | Micro Hub Blades, Micro Hub, Sterling, Blade, Gator | 3.5mm | Conmed/Linvatec | |
| MC9264 | Micro Hub Blades, Micro Hub, Sterling, Blade, Gator | 3.5mm | Conmed/Linvatec | |
| MC9263A | Micro Hub Blades, Micro Hub, Sterling, Blade, Gator | 4.2mm | Conmed/Linvatec | |
| C9950 | Micro Hub Blades, Micro Hub, Sterling®, Blade, Cuda | 2.0mm | Conmed/Linvatec | |
| C9951 | Micro Hub Blades, Micro Hub, Sterling, Blade, Cuda | 2.9mm | Conmed/Linvatec | |
| C9952 | Micro Hub Blades, Micro Hub, Sterling, Blade, Cuda | 3.5mm | Conmed/Linvatec | |
| MC9253 | Micro Hub Blades, Micro Hub, Sterling, Blade, Cuda | 3.5mm | Conmed/Linvatec | |
| MC9254 | Micro Hub Blades, Micro Hub, Sterling, Blade, Cuda | 4.2mm | Conmed/Linvatec | |
| MC9258 | Micro Hub Blades, Micro Hub, Sterling, Blade, Cuda | 4.8mm | Conmed/Linvatec | |
| MC9290 | Micro Hub Blade, Micro Hub, Sterling, Blade, Dragon, End Cutters | 3.5mm | Conmed/Linvatec | |
| MC9291 | Micro Hub Blades, Micro Hub, Sterling, Blade, Dragon, End Cutter | 4.2mm | Conmed/Linvatec | |
| MC9292 | Micro Hub Blades, Micro Hub, Sterling, Blade, Dragon, End Cutter | 5.5mm | Conmed/Linvatec | |
| C9981 | Micro Hub Blades, Micro Hub, Sterling, Blade, Slotted Whisker | 2.9mm | Conmed/Linvatec | |
| MC9274 | Micro Hub Blades, Micro Hub, Sterling, Blade, Slotted Whisker | 4.2mm | Conmed/Linvatec | |
| C9911A | Large Hub Burs and Routers, Large | |||
| Hub, Sterling, Bur, Spherical | 2.9mm | Image: bur | Conmed/Linvatec | |
| C9912 | Micro Hub Burs and Routers, | |||
| Micro Hub, Sterling, Bur, Spherical | 3.5mm | Image: bur | Conmed/Linvatec | |
| MH9111 | Micro Hub Burs and Routers, | |||
| Micro Hub, Sterling, Bur, Spherical | 4.5mm | Image: bur | Conmed/Linvatec | |
| MH9112 | Micro Hub Burs and Routers, | |||
| Micro Hub, Sterling, Bur, Spherical | 5.5mm | Image: bur | Conmed/Linvatec | |
| MH9102 | Micro Hub Burs and Routers, | |||
| Micro Hub, Sterling, Bur, Oval | 6.0mm | Image: bur | Conmed/Linvatec | |
| MC9106 | Micro Hub Burs and Routers, | |||
| Micro Hub, Sterling, Bur, Oval, Left | ||||
| Helix | 6.0mm | Image: bur | Conmed/Linvatec | |
| C9990 | Micro Hub Burs and Routers, | |||
| Micro Hub, Sterling, Router, Vortex | ||||
| Two Flutes | 2.9mm | Image: bur | Conmed/Linvatec | |
| C9991 | Micro Hub Burs and Routers, | |||
| Micro Hub, Sterling, Router, Vortex | ||||
| Two Flutes | 3.5mm | Image: bur | Conmed/Linvatec | |
| MH9131 | Micro Hub Burs and Routers, | |||
| Micro Hub, Sterling, Router, Vortex | ||||
| Two Flutes | 4.5mm | Image: bur | Conmed/Linvatec | |
| MH9132 | Micro Hub Burs and Routers, | |||
| Micro Hub, Sterling, Router, Vortex | ||||
| Two Flutes | 6.0mm | Image: bur | Conmed/Linvatec | |
| C9405A | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Ultracut | 4.2mm | Image: shaver | Conmed/Linvatec | |
| C9298A | Large Hub Shaver Blades, Large | |||
| Hub, Sterling, Shaver, Mako | 5.5mm | Image: shaver | Conmed/Linvatec | |
| 37GRW-ME-ZZ | Large Hub Shaver Blades, Large | |||
| Hub, Merlin, Shaver, Great White | 3.7mm | Image: shaver | Conmed/Linvatec | |
| C9299P | Large Hub Shaver Blades, Large | |||
| Hub, Merlin, Shaver, Great | ||||
| White,Pre-Bent 15° | 4.2mm | Image: shaver | Conmed/Linvatec |
4
5
6
7
8
9
Indications for Use
510(k) Number (if known) K172092
Device Name
Reprocessed Smith & Nephew Shavers/Burs
Indications for Use (Describe)
The Reprocessed Smith & Nephew shavers and burs are intended for use with the Smith & Nephew DYONICS Power II Shaver System control unit, for resection of soft and osseous tissues including but not limited to, use in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
10
| Reprocessed Single-Use Smith & Nephew Shavers & Burs Device Models Subject to Clearance |
|---|
| (63 Smith & Nephew devices in total) |
| OEM Model # | Description | Diameter | Picture | OEM |
|---|---|---|---|---|
| 7205316 | DYONICS Straight Blades, | |||
| TURBOWHISKER, Navy Blue Latch | 4.5mm | Image: DYONICS Straight Blades, TURBOWHISKER, Navy Blue Latch | Smith & Nephew | |
| 7205315 | DYONICS Straight Blades | |||
| TURBOTRIMMER, Powder Blue | ||||
| Latch | 4.5mm | Image: DYONICS Straight Blades TURBOTRIMMER, Powder Blue Latch | Smith & Nephew | |
| 7205310 | DYONICS Straight Blades | |||
| SYNOVATOR, Forest Green Latch | 4.5mm | Image: DYONICS Straight Blades SYNOVATOR, Forest Green Latch | Smith & Nephew | |
| 7205311 | DYONICS Straight Blades | |||
| SYNOVATOR, Melon Yellow Latch | 5.5mm | Image: DYONICS Straight Blades SYNOVATOR, Melon Yellow Latch | Smith & Nephew | |
| 7205308 | DYONICS Straight Blades Cutter, | |||
| Red Latch | 3.5mm | Image: DYONICS Straight Blades Cutter, Red Latch | Smith & Nephew | |
| 7205309 | DYONICS Straight Blades Cutter, | |||
| Blue Latch | 4.5mm | Image: DYONICS Straight Blades Cutter, Blue Latch | Smith & Nephew | |
| 7205305 | DYONICS Straight Blades Full | |||
| Radius, Beige Latch | 3.5mm | Image: DYONICS Straight Blades Full Radius, Beige Latch | Smith & Nephew | |
| 7205306 | DYONICS Straight Blades Full | |||
| Radius, Yellow Latch | 4.5mm | Image: DYONICS Straight Blades Full Radius, Yellow Latch | Smith & Nephew | |
| 7205341 | DYONICS POWER Shaver Blades, | |||
| 18cm working length Long Full | ||||
| Radius | 4.5mm | Image: DYONICS POWER Shaver Blades, 18cm working length Long Full Radius | Smith & Nephew | |
| 7205307 | DYONICS Straight Blades Full | |||
| Radius, Orange Latch | 5.5mm | Image: DYONICS Straight Blades Full Radius, Orange Latch | Smith & Nephew | |
| 7210751 | DYONICS Straight Blades Full | |||
| Radius ELITE, Beige Latch | 3.5mm | Image: DYONICS Straight Blades Full Radius ELITE, Beige Latch | Smith & Nephew | |
| 7210499 | DYONICS Straight Blades Full | |||
| Radius ELITE, Maroon Latch | 4.5mm | Image: DYONICS Straight Blades Full Radius ELITE, Maroon Latch | Smith & Nephew | |
| 7205317 | DYONICS Straight Blades | |||
| RAZORCUT, Purple Latch | 3.5mm | Image: DYONICS Straight Blades RAZORCUT, Purple Latch | Smith & Nephew | |
| 7205318 | DYONICS Straight Blades | |||
| RAZORCUT, Pink Latch | 4.5mm | Image: DYONICS Straight Blades RAZORCUT, Pink Latch | Smith & Nephew | |
| 7205319 | DYONICS Straight Blades | |||
| RAZORCUT, Light Pink | 5.5mm | Image: DYONICS Straight Blades RAZORCUT, Light Pink | Smith & Nephew | |
| 7205312 | DYONICS Straight Blades INCISOR, | |||
| Medium Grey Latch | 3.5mm | Image: DYONICS Straight Blades INCISOR, Medium Grey Latch | Smith & Nephew | |
| 7205313 | DYONICS Straight Blades INCISOR, | |||
| Lime Green Latch | 4.5mm | Image | Smith & Nephew | |
| 7205343 | DYONICS POWER Shaver Blades, | |||
| 18cm working length Long | ||||
| INCISOR | 4.5mm | Image | Smith & Nephew | |
| 7205314 | DYONICS Straight Blades INCISOR, | |||
| Mocha Latch | 5.5mm | Image | Smith & Nephew | |
| 7205345 | DYONICS Straight Blades INCISOR | |||
| Plus, Violet Latch | 4.5mm | Image | Smith & Nephew | |
| 7205459 | DYONICS Straight Blades INCISOR | |||
| Plus, Teal Latch | 5.5mm | Image | Smith & Nephew | |
| 7209303 | DYONICS Straight Blades Ultra | |||
| Series TURBOWHISKER, Navy | ||||
| Blue Latch | 4.5mm | Image | Smith & Nephew | |
| 7210976 | DYONICS Straight Blades INCISOR | |||
| Plus ELITE, Slate Latch | 4.5mm | Image | Smith & Nephew | |
| 72200081 | DYONICS Straight Blades INCISOR | |||
| Plus ELITE, Lilac Latch | 5.5mm | Image | Smith & Nephew | |
| 72200414 | DYONICS POWER Shaver Blades, | |||
| 18cm working length Long | ||||
| INCISOR Plus ELITE | 4.5mm | Image | Smith & Nephew | |
| 72200095 | DYONICS Straight Blades INCISOR | |||
| Plus ELITE, White Latch | 3.5mm | Image | Smith & Nephew | |
| 72104486 | DYONICS BONECUTTER Blades | |||
| Full Radius BONECUTTER, Beige | ||||
| Latch | 3.5mm | Image | Smith & Nephew | |
| 7206011 | DYONICS BONECUTTER Blades | |||
| Full Radius BONECUTTER, Yellow | ||||
| Latch | 4.5mm | Image | Smith & Nephew | |
| 7206010 | DYONICS BONECUTTER Blades | |||
| Full Radius BONECUTTER, Orange | ||||
| Latch | 5.5mm | Image | Smith & Nephew | |
| 7206013 | DYONICS BONECUTTER Blades | |||
| SYNOVATOR w/Full Radius inner | ||||
| BONECUTTER, Forest Green Latch | 4.5mm | Image | Smith & Nephew | |
| 7206012 | DYONICS BONECUTTER Blades | |||
| SYNOVATOR w/Full Radius inner | ||||
| BONECUTTER, Melon Yellow | ||||
| Latch | 5.5mm | Image | Smith & Nephew | |
| 7205324 | DYONICS Straight Burs Abrader, | |||
| Aqua Latch | 4.0mm | Image | Smith & Nephew | |
| 7205325 | DYONICS Straight Burs Abrader, | |||
| Black Latch | 5.5mm | Image | Smith & Nephew | |
| 7209335 | DYONICS Straight Burs Shielded, | |||
| White Latch | 4.5mm | Image | Smith & Nephew | |
| 7205326 | DYONICS Straight Burs | |||
| Acromionizer, Mauve Latch | 4.0mm | Smith & Nephew | ||
| 7205327 | DYONICS Straight Burs | |||
| Acromionizer, Brown Latch | 5.5mm | Smith & Nephew | ||
| 7205727 | DYONICS Straight Burs HELICUT, | |||
| Slate Latch | 4.5mm | Smith & Nephew | ||
| 7205328 | DYONICS Straight Burs | |||
| NOTCHBLASTER, Lilac Latch | 4.0mm | Smith & Nephew | ||
| 7205329 | DYONICS Straight Burs | |||
| NOTCHBLASTER, Peach Latch | 5.5mm | Smith & Nephew | ||
| 7205668 | DYONICS Straight Burs | |||
| ACROMIOBLASTER, Sage Green | ||||
| Latch | 4.0mm | Smith & Nephew | ||
| 7205669 | DYONICS Straight Burs | |||
| ACROMIOBLASTER, Brick Red | ||||
| Latch | 5.5mm | Smith & Nephew | ||
| 7205330 | DYONICS Straight Burs | |||
| STONECUTTER, Maroon Latch | 4.0mm | Smith & Nephew | ||
| 72200082 | DYONICS POWER Shaver Burrs, | |||
| 18cm working length, partial | ||||
| hood Long Abrader | 5.5mm | Smith & Nephew | ||
| 72200729 | DYONICS Straight Burs ELITE | |||
| STONECUTTER, Maroon Latch | 5.5mm | Smith & Nephew | ||
| 72200730 | DYONICS Straight Burs ELITE | |||
| ACROMIOBLASTER, Sage Green | ||||
| Latch | 4.0mm | Smith & Nephew | ||
| 72200724 | DYONICS Straight Burs ELITE | |||
| Acromionizer, Mauve Latch | 5.5mm | Smith & Nephew | ||
| 72203127 | DYONICS HIGH VISIBILITY Hip | |||
| Burrs HIGH VISIBILITY Sheath | ||||
| Abrader Burr | 5.5mm | Smith & Nephew | ||
| 72203521 | DYONICS Full Radius PLATINUM | |||
| Blades Full Radius PLATINUM | ||||
| Blade | 4.5mm | Smith & Nephew | ||
| 72200723 | DYONICS Straight Burs ELITE | |||
| Abrader, Black Latch | 5.5mm | Smith & Nephew | ||
| 72200728 | DYONICS Straight Burs ELITE | |||
| STONECUTTER, Maroon Latch | 4.0mm | Smith & Nephew | ||
| 72203128 | HIGH VISIBILITY Sheath Abrader | |||
| Burr | 4.0mm | Smith & Nephew | ||
| 72202530 | HIGH VISIBILITY Sheath Flat Top | |||
| Burr | 4.0mm | Smith & Nephew | ||
| 7205320 | ORBIT INCISOR™ | 4.5mm | Image | Smith & Nephew |
| 72200731 | ELITE ACROMIOBLASTER | 5.5mm | Image | Smith & Nephew |
| 72200727 | ELITE NOTCHBLASTER | 5.5mm | Image | Smith & Nephew |
| 72200726 | ELITE NOTCHBLASTER | 4.0mm | Image | Smith & Nephew |
| 7205331 | ELITE ACROMIOBLASTER | 5.5mm | Image | Smith & Nephew |
| 72202531 | BONECUTTER PLATINUM Blade | 4.5mm | Image | Smith & Nephew |
| 72203013 | DYONICS INCISOR Plus PLATINUM | 4.5mm | Image | Smith & Nephew |
| 72200725 | ELITE Acromionizer | 5.5mm | Image | Smith & Nephew |
| 7210486 | Full Radius BONECUTTER | 3.5mm | Image | Smith & Nephew |
| 72200722 | ELITE Abrader | 4.0mm | Image | Smith & Nephew |
| 3419 | Full Radius | 2.9mm | Image | Smith & Nephew |
11
12
13
14
Indications for Use
510(k) Number (if known) K172092
Device Name Reprocessed Stryker Shavers/Burs
Indications for Use (Describe)
The Reprocessed Styker Shavers and Burs are intended for use with the Styker Total Performance System Shaver handpiece and the Stryker Total Performance System by surgeons in the following orthopedic joints:
Knee
-
Shoulder
-
Ankle
-
Elbow
-
Wrist
-
Hip
-
Temporamandibular
The Reprocessed Styker Shavers and Burs will be used to resect tissue and bur bone.
Examples of uses of the product would include resection of torn knee cartilage, subacromial decompression and resection of synovial tissue in other joints.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
15
Reprocessed Single-Use Stryker Shavers & Burs Device Models Subject to Clearance (72 Stryker devices in total)
| OEM
| Model # | Description | Diameter | Picture | OEM |
|---|---|---|---|---|
| 375-535-000 | Formula Series Cutters, Tomcat Cutters | 3.5mm | Image: Tomcat Cutter | Stryker |
| 375-545-000 | Formula Series Cutters, Tomcat Cutters | 4.0mm | Image: Tomcat Cutter | Stryker |
| 375-555-000 | Formula Series Cutters, Tomcat Cutters | 5.0mm | Image: Tomcat Cutter | Stryker |
| 375-565-000 | Formula Series Cutters, Tomcat Cutters | 5.5mm | Image: Tomcat Cutter | Stryker |
| 375-542-000 | Formula Series Cutters, Resector Cutters | 4.0mm | Image: Resector Cutter | Stryker |
| 375-552-000 | Formula Series Cutters, Resector Cutters | 5.0mm | Image: Resector Cutter | Stryker |
| 375-562-000 | Formula Series Cutters, Resector Cutters | 5.5mm | Image: Resector Cutter | Stryker |
| 375-534-000 | Formula Series Cutters, Aggressive Plus Cutters | 3.5mm | Image: Aggressive Plus Cutter | Stryker |
| 375-544-000 | Formula Series Cutters, Aggressive Plus Cutters | 4.0mm | Image: Aggressive Plus Cutter | Stryker |
| 375-554-000 | Formula Series Cutters, Aggressive Plus Cutters | 5.0mm | Image: Aggressive Plus Cutter | Stryker |
| 375-564-000 | Formula Series Cutters, Aggressive Plus Cutters | 5.5mm | Image: Aggressive Plus Cutter | Stryker |
| 375-546-000 | Formula Series Cutters, Scalloped Cutter | 4.0mm | Image: Scalloped Cutter | Stryker |
| 375-566-000 | Formula Series Cutters, Scalloped Cutter | 5.5mm | Image: Scalloped Cutter | Stryker |
| 375-531-000 | Formula Series Cutters, Cougar End Cutter | 3.5mm | Image: Cougar End Cutter | Stryker |
| 375-541-000 | Formula Series Cutters, Cougar End Cutter | 4.0mm | Image: Cougar End Cutter | Stryker |
| 375-551-000 | Formula Series Cutters, Cougar End Cutter | 5.0mm | Image: Cougar End Cutter | Stryker |
| 375-737-000 | Formula Series Cutters, End Cutter | 3.5mm | Image: End Cutter | Stryker |
| 375-747-000 | Formula Series Cutters, End Cutter | 4.0mm | Image: End Cutter | Stryker |
| 375-757-000 | Formula Series Cutters, End Cutter | 5.0mm | Image: End Cutter | Stryker |
| 375-884-000 | Formula Series Cutters, True End Cutter | 4.0mm | Image: True End Cutter | Stryker |
| 375-543-000 | Formula Series Cutters, Double Bite Cutter | 4.0mm | Image: Double Bite Cutter | Stryker |
| 375-548-000 | Formula Series Cutters, Slotted Whisker Cutter | 4.0mm | Image: Slotted Whisker Cutter | Stryker |
| 375-558-000 | Formula Series Cutters, Slotted Whisker Cutter | 5.0mm | Image: Slotted Whisker Cutter | Stryker |
| 375-549-000 | Formula Series Cutters, Whisker Cutter | 4.0mm | Image: Whisker Cutter | Stryker |
| 375-941-012 | Standard 12 Flute Barrel Bur | 4.0mm | Image: Standard 12 Flute Barrel Bur | Stryker |
| 375-951-012 | Standard 12 Flute Barrel Bur | 5.5mm | Image: Standard 12 Flute Barrel Bur | Stryker |
| 375-941-000 | Aggressive 6 Flute Barrel Bur | 4.0mm | Image: Aggressive 6 Flute Barrel Bur | Stryker |
| 375-951-100 | Aggressive 6 Flute Barrel Bur | 5.0mm | Image: Aggressive 6 Flute Barrel Bur | Stryker |
| 375-951-000 | Aggressive 6 Flute Barrel Bur | 5.5mm | Image: Aggressive 6 Flute Barrel Bur | Stryker |
| 375-941-200 | Unhooded 6 Flute Barrel Bur | 4.0mm | Image: Unhooded 6 Flute Barrel Bur | Stryker |
| 375-951-200 | Unhooded 6 Flute Barrel Bur | 5.5mm | Image: Unhooded 6 Flute Barrel Bur | Stryker |
| 375-940-012 | Standard 12 Flute Round Bur | 4.0mm | Image: Standard 12 Flute Round Bur | Stryker |
| 375-950-112 | Standard 12 Flute Round Bur | 5.0mm | Image: Standard 12 Flute Round Bur | Stryker |
| 375-950-012 | Standard 12 Flute Round Bur | 5.5mm | Image: Standard 12 Flute Round Bur | Stryker |
| 375-930-000 | Aggressive 6 Flute Round Bur | 3.5mm | Image: Aggressive 6 Flute Round Bur | Stryker |
| 375-940-000 | Aggressive 6 Flute Round Bur | 4.0mm | Image: Aggressive 6 Flute Round Bur | Stryker |
| 375-950-100 | Aggressive 6 Flute Round Bur | 5.0mm | Image: Aggressive 6 Flute Round Bur | Stryker |
| 375-950-000 | Aggressive 6 Flute Round Bur | 5.5mm | Image: Aggressive 6 Flute Round Bur | Stryker |
| 375-940-200 | Unhooded 6 Flute Round Bur | 4.0mm | Image: Unhooded 6 Flute Round Bur | Stryker |
| 375-950-200 | Unhooded 6 Flute Round Bur | 5.5mm | Image: Unhooded 6 Flute Round Bur | Stryker |
| 375-941-200 | Unhooded 6 Flute Barrel Bur | 4.0mm | Image: Unhooded 6 Flute Barrel Bur | Stryker |
| 375-951-200 | Unhooded 6 Flute Barrel Bur | 5.5mm | Image: Unhooded 6 Flute Barrel Bur | Stryker |
| 375-952-000 | Egg Bur 6 Flute | 5.5mm | Image: bur | Stryker |
| 375-941-500 | Formula Series Specialty Bur, 6 Flute SLAP Bur | 4.0mm | Image: bur | Stryker |
| 375-450-500 | Formula Series Specialty Bur, Auger Bur | 5.0mm | Image: bur | Stryker |
| 375-832-000 | Formula Series Specialty Bur, Subchondral Drill | |||
| (1.5mm Drill Tip) | 4.0mm | Image: bur | Stryker | |
| 375-953-000 | Formula Series Specialty Burs, 6 Flute Left Helix | |||
| Barrel Bur | 5.5mm | Image: bur | Stryker | |
| 375-953-012 | Formula Series Specialty Burs, 12 Flute Left Helix | |||
| Barrel Bur | 5.5mm | Image: bur | Stryker | |
| 375-627-000 | Formula Series Cutters and Burs, Small-Joint, Full | |||
| Radius Cutter | 2.5mm | Image: bur | Stryker | |
| 375-637-000 | Formula Series Cutters and Burs, Small-Joint, Full | |||
| Radius Cutter | 3.5mm | Image: bur | Stryker | |
| 375-628-000 | Formula Series Cutters and Burs, Small-Joint, | |||
| Aggressive Plus Cutter | 2.5mm | Image: bur | Stryker | |
| 375-638-000 | Formula Series Cutters and Burs, Small-Joint, | |||
| Aggressive Plus Cutter | 3.5mm | Image: bur | Stryker | |
| 375-636-000 | Formula Series Cutters and Burs, Small-Joint, | |||
| Tomcat Cutter | 3.5mm | Image: bur | Stryker | |
| 375-641-000 | Formula Series Cutters and Burs, Small-Joint | |||
| Hooded Abrasion Bur | 2.0mm | Image: bur | Stryker | |
| 375-647-000 | Formula Series Cutters and Burs, Small-Joint | |||
| Hooded Abrasion Bur | 3.0mm | Image: bur | Stryker | |
| 385-544-000 | Formula Series | |||
| Hip Length Cutters & Burs, Aggressive Plus, Long | ||||
| Hip Blade | 4.0mm | Image: bur | Stryker | |
| 385-554-000 | Formula Series | |||
| Hip Length Cutters & Burs, Straight Aggressive | ||||
| Plus, Long Hip Blade | 5.0mm | Image: bur | Stryker | |
| 385-545-000 | Formula Series | |||
| Hip Length Cutters & Burs, Tomcat, Long Hip Blade | 4.0mm | Image: bur | Stryker | |
| 385-552-000 | Formula Series | |||
| Hip Length Cutters & Burs, Straight Resector, Long | ||||
| Hip Blade | 5.0mm | Image: bur | Stryker | |
| 385-943-000 | Formula Series | |||
| Hip Length Cutters & Burs, Long Hip 8 Flute Pear | ||||
| Bur | 4.0mm | Image: bur | Stryker | |
| 385-953-008 | Formula Series | |||
| Hip Length Cutters & Burs, Long Hip 8 Flute Pear | ||||
| Bur | 5.5mm | Image: bur | Stryker | |
| 385-951-008 | Formula Series | |||
| Hip Length Cutters & Burs, Long Hip 8 Flute Round | ||||
| Bur | 5.5mm | Image: bur | Stryker | |
| 385-950-008 | Formula Series | |||
| Hip Length Cutters & Burs, Long Hip 8 Flute Barrel | ||||
| Bur | 5.5mm | Image: Stryker | Stryker | |
| 275-628-000 | Small Joint Cutters & Burs, Small Joint Aggressive | |||
| Cutter | 2.5mm | Image: Stryker | Stryker | |
| 275-627-000 | Small Joint Cutters & Burs, Small Joint Full Radius | |||
| Cutter | 2.5mm | Image: Stryker | Stryker | |
| 275-637-000 | Small Joint Cutters & Burs, Small Joint Full Radius | |||
| Cutter | 3.5mm | Image: Stryker | Stryker | |
| 275-638-000 | Small Joint Cutters & Burs, Small Joint Aggressive | |||
| Cutter | 2.5mm | Image: Stryker | Stryker | |
| 275-641-000 | Small Joint Cutters & Burs, Small Joint Hooded | |||
| Abrasion Bur | 2.0mm | Image: Stryker | Stryker | |
| 275-647-000 | Small Joint Cutters & Burs, Small Joint Hooded | |||
| Abrasion Bur | 3.0mm | Image: Stryker | Stryker | |
| 275-831-000 | Small Joint Cutters & Burs, Small Joint Round Bur | 3.0mm | Image: Stryker | Stryker |
| 375-951-112 | Standard 12 Flute Barrel Bur | 5.0mm | Image: Stryker | Stryker |
| 375-532-000 | Resector Cutter | 3.5mm | Image: Stryker | Stryker |
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
SUBMITTER ReNovo, Inc. Mark K. Wells 340 SW Columbia St. Bend OR, 97702 USA Tel: +1.541.422.8880 Fax: +1.541.422.8881
II. CONTACT PERSON
Robert Packard, President of Medical Device Academy 345 Lincoln Hill Rd. Shrewsbury, VT 05738 USA Tel: +1.802.281.4318 Email: rob@13485cert.com
Date Prepared: October 2, 2017
III. DEVICE
| Name of Device: | Reprocessed Shavers/Burs |
|---|---|
| Classification Name: | Arthroscope |
| Regulation: | 21 CFR §888.1100 |
| Regulatory Class: | Class II |
| Product Classification Code: | HRX |
OEM/PREDICATE DEVICES IV.
| Predicate Manufacturer: | Stryker Endoscopy |
|---|---|
| Predicate Trade Name: | Total Performance System Shaver |
| Predicate 510(k): | K973195 |
| Predicate Manufacturer: | Linvatec Corporation |
| Predicate Trade Name: | Integrated Drive/Pump System |
| Predicate 510(k): | K981636 |
| Predicate Manufacturer: | Smith & Nephew, Inc., Endoscopy Division |
| Predicate Trade Name: | DYONICS Power II Shaver System |
| Predicate 510(k): | K062849 |
V. DEVICE DESCRIPTION
The Reprocessed Shavers and Burs are intended to be used for arthroscopic and laparoscopic surgical techniques. Shavers have sharp rotating inner blades housed in an outer shaft designed to cut tissue. Burs have an abrasive wearing surface that rotate in an outer sheath to grind down bone. The housing has a window cut out on one side of the distal end, allowing the bur to cut one part of the intended anatomy, while the adjacent one is still protected by the housing on the opposite side of the abrader, bur or blade.
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There are various configurations of diameter, length, and cutting or grinding surfaces. The materials of construction are generally: metal shafts, lubricants (between the inner and outer components to reduce friction and heat), and polymer hubs bonded to the shafts. The polymer hub connects to a user-supplied motorized hand piece, which drives the internal abrader, bur or blade inside the outer housing. The handpiece provides suction to remove tissue which has been cut during the surgical procedure.
There are 39 Stryker shavers and 33 Stryker burs included in this submission. The Stryker shavers and burs are used with the Total Performance System Shaver handpiece is made of a motor housing with a coupling mechanism to secure the shavers/burs to the handpiece. The Stryker shavers and burs are intended to be used to resect tissue and bur bone in orthopedic joints such as the knee, shoulder, ankle, elbow, wrist, hip, etc.
There are 31 Smith & Nephew shavers and 32 Smith & Nephew burs included in this submission. The Smith & Nephew shavers and burs are intended to be used with the Smith & Nephew DYONICS Power II Shaver System control unit. This system is compatible with DYONICS POWER handpieces. It can be used in large or small joint cavities or in sinus surgery.
There are 94 ConMed/Linvatec shavers and 26 ConMed/Linvatec burs included in this submission. The Linvatec shavers and burs are intended to be used with the Linvatec Integrated Drive/Pump system. The system has three different handpieces that ca be used for otolaryngology, neurological surgical, orthopedic, and spinal procedures.
VI. INDICATIONS FOR USE
The Reprocessed Linvatec shavers and burs are intended for use with the Linvatec Integrated Drive/Pump System to perform resection of soft tissue and bone. The fields of application include Otolaryngology, Neurological Surgical, Orthopedic, and Spinal surgical procedures.
The Reprocessed Smith & Nephew shavers and burs are intended for use with the Smith & Nephew DYONICS Power II Shaver System control unit, for resection of soft and osseous tissues including but not limited to, use in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure.
The Reprocessed Styker Shavers and Burs are intended for use with the Styker Total Performance System Shaver handpiece and the Stryker Total Performance System by surgeons in the following orthopedic joints:
Knee
-
Shoulder
-
Ankle
-
Elbow
-
Wrist
-
Hip
-
Temporamandibular
The Reprocessed Styker Shavers and Burs will be used to resect tissue and bur bone. Examples of uses of the product would include resection of torn knee cartilage, subacromial decompression and resection of synovial tissue in other joints.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE OEM PREDICATE DEVCE
The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:
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- Indications for Use - The predicates and subject devices have equivalent indications for use; all are indicated for the resection of soft tissue and bone.
- . Materials - The predicate and subject device materials are equivalent. The lubricants are not identical, but are equivalent in functional and biocompatible performance. The predicate device and subject device materials are identical to their respective predicate (OEM) devices, with the exception of the lubricant.
- Design The predicate and subject devices are identical in design. .
- Energy Source - The subject devices are not in themselves powered, but are powered by a userprovided handpiece. For the subject devices, the handpiece is the same handpiece used by the predicate (OEM).
- Performance Testing - The subject devices are reprocessed versions of the predicate (OEM) devices. The OEM devices are performance-tested cleared medical devices; therefore the performance testing consisted of side-by-side testing of the reprocessed devices to an identical new OEM device. The subject device was tested for sharpness and bending after three reprocessing cycles, and performed equivalently to the OEM device.
- . Cleaning Validation - While it is very important to test the performance of the reprocessed device to ensure it performs as new; an important part of the risk management of a reprocessed device is the need to ensure cleanliness. A cleaning validation was performed to ensure that the reprocessing steps thoroughly cleaned and sanitized the devices so that they were as clean as a new OEM device.
VIII. SAFTEY AND PERFORMANCE DATA
The following safety and performance data is provided in support of the substantial equivalence determination.
Performance Testing
- . Functional Testing
- Performance testing comparison against new OEM device (sharpness and bending) O
- Drop Testing comparison against new OEM device O
- Product Stability
- Shelf Life Testing 1-Year Accelerated Aging O
Biocompatibility Testing
- · Cytotoxicity
- · Irritation
- · Acute Systemic Toxicity
- · Material Mediated Pyrogenicity
- · Sensitization
Cleaning Validation
- Residual Protein and Carbohydrates .
- Visual Inspection ●
- . Cleaning Performance Qualification
Sterilization and Packaging
- EtO Sterilization Validation ●
- EtO Residuals Testing ●
- Simulated Shipment Testing
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Electrical Safety and EMC Testing
Electrical safety and EMC testing were not applicable.
Animal Testing
Animal performance testing was not required to demonstrate safety and effectiveness.
Clinical Testing
Clinical testing was not required to demonstrate the safety and effectiveness of the Reprocessed Shavers/Burs. Substantial equivalence is based upon benchtop performance testing.
CONCLUSIONS IX.
Side by side testing ensured that the shavers and burs performed equivalently to the same device new from the OEM. Cleaning validations ensured that the devices are reprocessed and cleaned to the condition of a new OEM device. Therefore, based on a comparison of technological characteristics, indications for use, and performance comparison data, it can be concluded that the proposed Reprocessed Shavers/Burs are substantially equivalent to the OEM predicate device.