(62 days)
Intended Use
CORIOGRAPH Pre-Op Planning and Modeling Service is intended to provide pre-operative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
Indications for Use
The CORIOGRAPH Pre-op Planning and Modeling Service is indicated for use for the following procedures:
- unicondylar knee replacement (UKR)
- . total knee arthroplasty (TKA)
The subject CORIOGRAPH Knee Pre-Op Plan is a medical function module within the CORIOGRAPH Pre-Op Planning and Modeling Service. This service is an additional offering being introduced by Smith & Nephew to allow for preoperative planning for surgical procedures based on patient imaging for total knee arthroplasty (TKA) and unicondylar knee replacement (UKR). The CORIOGRAPH Knee Pre-Op Plans will be generated for specific patients and anatomy by Smith and Nephew personnel using the CORIOGRAPH Knee Pre-Op Plan Software System V1.0, which is the subject of this submission. The CORIOGRAPH Knee Pre-Op Plans will output bone models of the patient anatomy and will generate patient-specific pre-operative plans which may be used on the REAL INTELLIGENCE CORI Surgical System.
The provided text is a 510(k) summary for the CORIOGRAPH Knee Pre-Op Plan. It discusses the device's substantial equivalence to a predicate device and details non-clinical testing. However, it does not contain the specific information required to complete all sections of your request regarding acceptance criteria and a study proving those criteria are met.
Here's a breakdown of what can be answered and what information is missing:
1. A table of acceptance criteria and the reported device performance
The document states, "Verification and validation testing demonstrated the safety and effectiveness of the software applications used in the CORIOGRAPH Knee Pre-Op Plan and demonstrated the safety and effectiveness of the generated CORIOGRAPH Knee Pre-Op Plan when used as an input to the CORI Surgical System. Summative usability testing demonstrated that participating surgeons were able use the subject device safely and effectively in a simulated use environment. Smith and Nephew, Inc. has concluded that all design inputs have been met and that the verification and validation testing performed did not raise any new questions of safety or effectiveness."
This is a general statement of compliance, not a detailed table of specific acceptance criteria (e.g., accuracy metrics, specific tolerances) and their corresponding reported performance values. Therefore, a table cannot be fully constructed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the text. The document refers to "verification and validation testing" and "summative usability testing" but does not specify the sample size for these tests or the origin/nature of the data used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the text. The document mentions "participating surgeons" in the usability testing, but their number or specific qualifications (beyond being surgeons) are not detailed. It does not mention experts establishing ground truth for a test set in the context of performance metrics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the text.
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
The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is a "Knee Pre-Op Plan" which suggests it aids in surgical planning, not necessarily in interpretation tasks typically associated with MRMC studies with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document states, "Verification and validation testing demonstrated the safety and effectiveness of the software applications used in the CORIOGRAPH Knee Pre-Op Plan and demonstrated the safety and effectiveness of the generated CORIOGRAPH Knee Pre-Op Plan when used as an input to the CORI Surgical System." This implies standalone testing of the software's output, as well as its interaction as an input to another system. However, specific metrics of "algorithm-only" performance are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not explicitly provided in the text. Given the device provides "pre-operative planning for surgical procedures based on patient imaging," the ground truth for evaluating its accuracy would likely be related to the accuracy of anatomical landmark identification, implant positioning, or surgical outcomes, but this is not specified.
8. The sample size for the training set
This information is not provided in the text. The document discusses "software applications" and "planning tools and processes" but does not detail any machine learning models or training sets.
9. How the ground truth for the training set was established
This information is not provided in the text, as no training set details are given.
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March 18, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Smith & Nephew, Inc Wilcox Miriam Sr. Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116
Re: K240113
Trade/Device Name: CORIOGRAPH Knee Pre-Op Plan Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 16, 2024 Received: January 16, 2024
Dear Wilcox Miriam:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali-S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
CORIOGRAPH Knee Pre-Op Plan
Indications for Use (Describe)
Intended Use
CORIOGRAPH Pre-Op Planning and Modeling Service is intended to provide pre-operative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
Indications for Use
The CORIOGRAPH Pre-op Planning and Modeling Service is indicated for use for the following procedures:
- · unicondylar knee replacement (UKR)
- · total knee arthroplasty (TKA)
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
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Smith & Nephew, Inc.
1450 Brooks Road Memphis, TN 38116 USA
T: + 1-901-396-2121 T: + 1-800-821-5700 (USA toll free) www.smith-nephew.com
Smith Nephew
510(k) Summary
| 510(k) Owner | Smith & Nephew, Inc.1450 Brooks RoadMemphis, Tennessee 38116 |
|---|---|
| Contact Person | Miriam WilcoxSenior Regulatory Affairs SpecialistEmail: miriam.wilcox@smith-nephew.com |
| Date Prepared | 18-March-2023 |
| Classification Reference | 21 CFR 888.3030 |
| Product Code | PBF |
| Supported Codes | JWH, MBH, OOG, HSX |
| Common/Usual Name | Orthopaedic Surgical Planning and Instrument Guides |
| Trade/Proprietary Name | CORIOGRAPH Knee Pre-Op Plan |
| Predicate Device(s) | VISIONAIRE UK Patient Matched Cutting Guides (K211512) |
| Reason for Submission | This Traditional 510(k) submission is seeking clearance for a newoffering, CORIOGRAPH Knee Pre-Op Plan V1.0, a module of theCORIOGRAPH Pre-Op Planning and Modeling Service |
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Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 USA
-821-5700 (USA toll free) -nephew.com
Intended Use
CORIOGRAPH Pre-Op Planning and Modeling Service is intended to provide pre-operative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
Indications for Use
The CORIOGRAPH Pre-op Planning and Modeling Service is indicated for use for the following procedures:
- unicondylar knee replacement (UKR)
- . total knee arthroplasty (TKA)
Device Description
The subject CORIOGRAPH Knee Pre-Op Plan is a medical function module within the CORIOGRAPH Pre-Op Planning and Modeling Service. This service is an additional offering being introduced by Smith & Nephew to allow for preoperative planning for surgical procedures based on patient imaging for total knee arthroplasty (TKA) and unicondylar knee replacement (UKR). The CORIOGRAPH Knee Pre-Op Plans will be generated for specific patients and anatomy by Smith and Nephew personnel using the CORIOGRAPH Knee Pre-Op Plan Software System V1.0, which is the subject of this submission. The CORIOGRAPH Knee Pre-Op Plans will output bone models of the patient anatomy and will generate patient-specific pre-operative plans which may be used on the REAL INTELLIGENCE CORI Surgical System.
{5}------------------------------------------------
Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 USA
: + 1-901-396-2121 T: + 1-800-821-5700 (USA toll free) www.smith-nephew.com
Currently Supported Knee Implants
The CORIOGRAPH Knee Pre-Op Plan is compatible with implant systems aligned to those supported with the REAL INTELLIGENCE CORI Surgical System. Compatible implant systems and clearance numbers are provided in Table 1.
TABLE 1. CURRENTLY SUPPORTED SMITH+ NEPHEW KNEE IMPLANTS FOR THE CORIOGRAPH KNEE PRE-OP PLAN V1.0
| Implant Model Name | 510(k) Number | ClassificationProduct Code |
|---|---|---|
| JOURNEY II Unicompartmental Knee System | K191211 | HSX |
| JOURNEY UNI | K102069 | HSX |
| JOURNEY II CR | K121443 | JWH |
| JOURNEY II BCS | K111711 | JWH |
| JOURNEY II XR | K141471, K152726 | JWH |
| LEGION CR/PS | K951987, K962557, K093746 | JWH |
| LEGION Porous CR Femoral Components | K073325, K091543 | MBH |
| LEGION Porous CR Narrow Femoral Components | K210566 | MBH |
| LEGION Porous Tibia | K100897 | MBH |
| Porous Tibia Baseplate | K211221 | MBH |
| GENESIS II CR/PS | K951987, K962557 | JWH |
| ANTHEM | K142807 | JWH |
| LEGION Knee System | K180334 | JWH, MBH |
REAL INTELLIGENCE CORI Surgical System Compatibility
The CORIOGRAPH Knee Pre-Op Plan is compatible with the following versions of the REAL INTELLIGENCE CORI surgical system.
TABLE 2. CURRENTLY SUPPORTED SYSTEM COMPATIBILITY FOR THE CORIOGRAPH KNEE PRE-OP PLAN V1.0
| Device Name | Version | 510(k) Number | ClassificationProduct Code |
|---|---|---|---|
| REAL INTELLIGENCE CORI | 3.0 | K240139 | HSX |
Discussion of Similarities and Differences
The purpose of this Traditional 510(k) submission is to seek clearance for the CORIOGRAPH Knee Pre-Op Plan V1.0, which is a medical function module of the CORIOGRAPH Pre-Op Planning and Modeling Service. This Software as a Medical Device (SaMD) is based on the VISIONAIRE Patient-Matched Technology Software Process also used to generate preoperative plans and physical instruments by the predicate device VISIONAIRE Patient-Matched Cutting Guides (K211512).
The modifications made to the VISIONAIRE Patient-Matched Technology Software Process include an update to a software application to allow for:
- A new pre-operative planning workflow within the software application. This workflow will use the same implant database used on the CORI Surgical System.
- Added ability to detect if the case is intended for Visionaire Patient Matched Cutting Guide or for CORIOGRAPH Pre-operative planning from the surgeon inputs.
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1-800-821-5700 (USA toll free) www.smith-nephew.com
- . Added ability to create a .json file and pre-operative plan images as outputs for pre-operative planning workflow.
- Implementation of minor bug fixes.
The software planning tools and processes used for the CORIOGRAPH Knee Pre-Op Plan have similar intended use, indications for use and technological characteristics as the software planning tools used for the preoperative plans generated for surgeon concurrence in the predicate VISIONAIRE UK Patient Matched Cutting Guides (K211512).
Smith & Nephew believes that CORIOGRAPH Knee Pre-Op Plan V1.0 is subject to premarket notification requirements under Section 510(k) of the Federal Food, Drug and Cosmetic Act ("FFDCA" or "the Act") and is substantially equivalent to the previously cleared REAL INTELLIGENCE CORI (K221224).
TABLE 3. PREDICATE DEVICE
| Manufacturer | Description | Submission Number | Clearance Date |
|---|---|---|---|
| Smith & Nephew, Inc | VISIONAIRE UK PatientMatched Cutting Guides | K211512 | 09/16/2021 |
Substantial equivalence analysis for the CORIOGRAPH Knee Pre-Op Plan is provided in Table 4.
TABLE 4. SUBSTANTIAL EQUIVALENCE TABLE
| Design AspectReviewed | CORIOGRAPH Knee Pre-OpPlan(Subject Device) | VISIONAIRE UK PatientMatched Cutting Guides(Predicate Device) | Comparison |
|---|---|---|---|
| 510(k) Number | K240113 | K211512S.E. 09/16/2021 | N/A |
| Manufacturer | Smith & Nephew, Inc. | Smith & Nephew, Inc. | Same as predicate |
| Design AspectReviewed | CORIOGRAPH Knee Pre-OpPlan(Subject Device) | VISIONAIRE UK PatientMatched Cutting Guides(Predicate Device) | Comparison |
| Indications forUse | Intended UseCORIOGRAPH Pre-operativePlanning Service is intendedto provide pre-operativeplanning for surgicalprocedures based on patientimaging, provided thatanatomic landmarksnecessary for alignment andpositioning of the implantare identifiable on patientimaging scans.Indications for UseThe CORIOGRAPH Pre-operative Planning Service isindicated for use for thefollowing procedures:unicondylar kneereplacement (UKR)total knee arthroplasty(TKA) | Smith & Nephew'sVISIONAIRE UK PatientMatched Cutting Guides areintended to be used aspatient-specific surgicalinstrumentation to assist inthe positioning of kneereplacement componentsintra-operatively and inguiding the marking of bonebefore cutting provided thatanatomic landmarksnecessary for alignment andpositioning of the implantare identifiable on patientimaging scans.The Smith & NephewVISIONAIRE UK PatientMatched Cutting Guides areintended for use with thefollowing existing Smith &Nephew, Inc. Knee Systemsand their cleared indicationsfor use:Genesis II Knee SystemLegion Knee SystemJourney BCS KneeSystemJourney II Knee SystemJOURNEY IIUnicompartmental Knee(JOURNEY II UK) System(K190085)The Smith & NephewVISIONAIRE UK PatientMatched Cutting Guides areintended for single use only. | Substantially equivalent -Intended use is modified toreflect that the output is asoftware file instead of aphysical patient-matchedpart. The indications for useare updated to reflect thesurgical procedures insteadof the specific implantsystems. As the softwareoutput is used within theCORI surgical system, thedevice is not limited bymanufacture of physicalparts. Compatible ImplantSystems will be disclosed inthe case management portal |
| TargetPopulation | Patients who are able toundergo an MRI safely, fitthe indications, and do notpresent anycontraindications for theexisting knee implant systemto which it is designed. | Patients who are able toundergo an MRI safely, fitthe indications, and do notpresent anycontraindications for theexisting knee implant systemto which it is designed. | Same as predicate |
| TargetAnatomy | Knee | Knee | Same as predicate |
| CORIOGRAPH Knee Pre-OpPlan(Subject Device) | VISIONAIRE UK PatientMatched Cutting Guides(Predicate Device) | Comparison | |
| Design AspectReviewed | |||
| Where used | Professional healthcare facility | Professional healthcare facility | Same as predicate |
| CompatibleTotal KneeSystems | Genesis II CRGenesis II PSLEGION CRLEGION CR PorousLEGION CR Narrow PorousLEGION PSJourney II BCSJourney II CRJourney II XRJourney II BCS ROXJourney II CR ROXJourney II UKJourney Uni | Genesis II CRGenesis II PSLEGION CRLEGION PSJourney II BCSJourney II CRJourney II XRJOURNEY IIUnicompartmental Knee(JOURNEY II UK) | Substantially equivalent - Asa software device,compatible implant systemsfor the subject device arealigned with implants clearedfor use with the CORISurgical System, whilecompatible implants for thepredicate device weredefined by cleared productofferings for physical patientmatched guides. |
| Design TypeOutput | Patient MatchedPreoperative surgical planprovided in PDF for surgeonreview. After surgeonacceptance of the planparameters, PDF and/orsoftware file is provided tobe used as an input torobotic surgical system. | Patient MatchedPreoperative surgical planprovided in PDF for surgeonreview. After surgeonacceptance of the planparameters, Physical PatientMatched Cutting Block isprovided. | Same as predicateSubstantially equivalent -Final output is a software fileinstead of a physical patient-matched cutting guide |
| Common Name | Orthopaedic SurgicalPlanning and InstrumentGuides | Knee Prosthesis | Substantially Equivalent -Output of Pre-Operative planis SaMD instead of a physicalguide, therefore productcode is updated to reflectoutput. |
| Device Class | Class II | Class II | Same as predicate |
| DeviceClassificationName andReference | 21 CFR 888.3030 -Single/multiple componentmetallic bone fixationappliances and accessories. | 21 CFR 888.3520- Knee JointFemorotibial metal/polymernonconstrained cementedprosthesis21 CFR 888.3560- Knee JointPatellofemorotibialpolymer/metal/polymersemi-constrained cementedprosthesis | Substantially Equivalent -Output of Pre-Operative planis SaMD instead of a physicalguide, therefore productcode is updated to reflectoutput. |
| Panel Code | Orthopaedics/87 | Orthopaedics/87 | Same as predicate |
| Product Code | PBF | HSXOOG | Substantially Equivalent -Output of Pre-Operative planis SaMD instead of a physicalguide, therefore productcode is updated to reflectoutput. |
| Design AspectReviewed | CORIOGRAPH Knee Pre-OpPlan(Subject Device) | VISIONAIRE UK PatientMatched Cutting Guides(Predicate Device) | Comparison |
| SupportedProduct Code | JWHMBHOOGHSX | JWHMBHOOGHSX | Same as predicate |
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Smith Nephew
Smith & Nephew, Inc.
1450 Brooks Road Memphis, TN 38116
USA T: + 1-901-396-2121 T: + 1-800-821-5700 (USA toll free) www.smith-nephew.com
{8}------------------------------------------------
Smith Nephew
Smith & Nephew, Inc.
1450 Brooks Road Memphis, TN 38116
USA T: + 1-901-396-2121 T: + 1-800-821-5700 (USA toll free) www.smith-nephew.com
{9}------------------------------------------------
Smith & Nephew, Inc. 1450 Brooks Road Memnhis TN 38116
USA
5700 (USA toll free) ephew.com
Non-Clinical Testing (Bench)
Verification and validation testing demonstrated the safety and effectiveness of the software applications used in the CORIOGRAPH Knee Pre-Op Plan and demonstrated the safety and effectiveness of the generated CORIOGRAPH Knee Pre-Op Plan when used as an input to the CORI Surgical System. Summative usability testing demonstrated that participating surgeons were able use the subject device safely and effectively in a simulated use environment. Smith and Nephew, Inc. has concluded that all design inputs have been met and that the verification and validation testing performed did not raise any new questions of safety or effectiveness.
Conclusion
The software tools and process used for CORIOGRAPH Knee Pre-Op Plan have similar intended use and indications for use and the same technological characteristics used in the software planning tools and processes used for the preoperative plans generated for the predicate VISIONAIRE UK Patient Matched Cutting Guides (K211512). The differences between the two systems include an update to support the implant database used by the CORI Surgical System as well as a modification of the output to include a JSON file and preoperative plan images for use on the CORI Surgical System.
Verification testing demonstrated that the system meets required design inputs. Summative usability testing results demonstrate that representative users can use the safely and effectively in a simulated use environment. The information presented in this 510(k) premarket notification demonstrates that the CORIOGRAPH Knee Pre-Op Plan System may be used to generative plans for surgical procedures based on patient imaging. This information also demonstrates that the CORIOGRAPH Knee Pre-Op Plan system is as safe and effective as the software and planning process used in the predicate VISIONAIRE UK Patient Matched Cutting Guides (K211512). Smith and Nephew, Inc. believes that FDA can find CORIOGRAPH Knee Pre-Op Plan V1.0 to be substantially equivalent to the predicate device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.