(268 days)
The CEPTRE® Knotted UHMWPE Suture PEEK Anchor are indicated in surgical procedures for soft tissue fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder and hip for the following indications:
-
- Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair Capsular Shift or Capsulolabral Reconstruction.
-
- Foot Ankle: Lateral Stabilization, Medial stabilization, Achilles Tendon repair, Hallux Valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair, Digital tendon transfers and Bunionectomy.
-
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral ligament repair, Lateral collateral ligament repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Iliotibial band tenodesis.
-
- Hand/Wrist: Scapholunate ligament reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital tendon transfers.
-
- Elbow: Biceps tendon reattachment, Tennis Elbow Repair, Ulnar or Radial collateral ligament reconstruction, and lateral Epicondylitis repair.
-
- Hip: Acetabular labral repair, Capsular repair and gluteus medius repair.
The CEPTRE® Knotted UHMWPE Suture PEEK Anchors are available as Screw Anchor (threaded) & Wedge Anchor (Tap in) which are preloaded with suture(s), tape(s) or suture-tape combinations on a disposable inserter assembly. The implant is supplied sterile and ready to use.
The provided document describes a 510(k) premarket notification for a medical device called the CEPTRE® Knotted UHMWPE Suture PEEK Anchor. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical effectiveness study. Therefore, some of the requested information, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, and training set information, is not applicable or not provided in this specific type of regulatory document.
However, the document does contain information regarding acceptance criteria in the form of performance data and the study undertaken to demonstrate substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the CEPTRE® Knotted UHMWPE Suture PEEK Anchor are based on demonstrating mechanical performance statistically equivalent to the predicate devices. The document reports that the device successfully met these criteria.
| Acceptance Criteria (Measured Performance) | Reported Device Performance (CEPTRE® Knotted UHMWPE Suture PEEK Anchor) |
|---|---|
| Pull-out strength (from bone) | Statistically equivalent to predicate device |
| Cyclical loading | Statistically equivalent to predicate device |
| Drive in torque | Statistically equivalent to predicate device |
| Bacterial Endotoxin (USP <85> pyrogen limit specifications) | Meets pyrogen limit specifications |
| Packaging integrity (post-sterilization, during shipping/handling) | Confirmed to provide protective sterile barrier and protect product integrity |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for the mechanical tests (pull-out strength, cyclical loading, drive-in torque) or for bacterial endotoxin and packaging tests. For regulatory submissions like 510(k), it is common to use statistically significant sample sizes, but the explicit numbers are often not included in the public summary.
- Data Provenance: The studies are non-clinical, likely conducted in a laboratory setting. There is no information on country of origin for the data or whether it was retrospective or prospective, as these terms typically apply to clinical studies with human participants.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device, being a mechanical implant, does not involve diagnostic interpretation or ground truth established by medical experts in the way a diagnostic imaging AI would. The "ground truth" for the performance tests is the objective measurement of mechanical properties and biological safety.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this involves objective mechanical and biological safety testing, not subjective interpretation requiring adjudication.
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
Not applicable. This is not an AI-powered diagnostic device, but a physical surgical implant. Therefore, MRMC studies and human reader improvement with AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical, non-AI medical device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established through:
- Objective Mechanical Measurements: For pull-out strength, cyclical loading, and drive-in torque, the truth is the quantitative force, cycles, and torque measured according to established engineering and material science standards.
- Biological Safety Standards: For bacterial endotoxin, the truth is defined by the pyrogen limit specifications outlined in USP <85>.
- Packaging Performance Standards: For packaging, the truth is established by the ability of the packaging to maintain sterility and product integrity under defined conditions.
These are all objective, measurable criteria, not subjective expert consensus or pathology.
8. The Sample Size for the Training Set
Not applicable. This is a physical product, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As this device does not use a training set, this information is not relevant.
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January 4, 2024
Image /page/0/Picture/1 description: The image contains 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 the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Healthium Medtech Limited Pankaj Dawar Deputy General Manager Regulatory Affair 472-D, 13th Cross, 4th Phase, Peenya Industrial Area Bangalore, Karnataka 560058 India
Re: K231033
Trade/Device Name: CEPTRE® Knotted UHMWPE Suture PEEK Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: December 2, 2023 Received: December 4, 2023
Dear Pankaj Dawar:
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"
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(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).
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 OS 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.
Digitally signed by Jesse
Jesse Muir -S Muir-S
Date: 2024.01.04 10:17:30
-05'00'
Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality
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Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231033
Device Name
CEPTRE® Knotted UHMWPE Suture PEEK Anchor
Indications for Use (Describe)
The CEPTRE® Knotted UHMWPE Suture PEEK Anchor are indicated in surgical procedures for soft tissue fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder and hip for the following indications:
-
- Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair Capsular Shift or Capsulolabral Reconstruction.
-
- Foot Ankle: Lateral Stabilization, Medial stabilization, Achilles Tendon repair, Hallux Valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair, Digital tendon transfers and Bunionectomy.
-
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral ligament repair, Lateral collateral ligament repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Iliotibial band tenodesis.
-
- Hand/Wrist: Scapholunate ligament reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital tendon transfers.
-
- Elbow: Biceps tendon reattachment, Tennis Elbow Repair, Ulnar or Radial collateral ligament reconstruction, and lateral Epicondylitis repair.
-
- Hip: Acetabular labral repair, Capsular repair and gluteus medius repair.
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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Image /page/4/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font.
Image /page/4/Picture/1 description: The image contains the text 'K231033' at the top. Below that is a logo for 'Healthium'. The logo consists of the word 'Healthium' in a bold, sans-serif font, with a stylized graphic to the right. The graphic appears to be two overlapping circles, one blue and one orange, with a white cross shape imposed over them.
1. 510(k) Summary
1.1. Submitter Information:
| Application Correspondent: | PANKAJ DAWAR |
|---|---|
| Healthium Medtech Limited | |
| 472-D, 13th Cross, 4th Phase, | |
| Peenya Industrial Area, | |
| Bangalore Karnataka 560058, India | |
| Phone: | +91-9886529934 |
| E-mail: | pankaj.d@healthiummedtech.com |
| Specification Developer: | Healthium Medtech Limited |
| 472-D, 13th Cross, 4th Phase, | |
| Peenya Industrial Area, | |
| Bangalore, Karnataka 560058, India | |
| Phone: | +91 - 80 - 41868000 |
| Contact Person: | PANKAJ DAWAR |
| E-mail: | pankaj.d@healthiummedtech.com |
| Date Prepared: | 03-01-2024 |
| 1.2. Device Identification: | |
| Device Trade Name: | CEPTRE® Knotted UHMWPE Suture PEEK Anchor. |
| Device Common Name: | Non-Absorbable Suture Anchor |
| Classification Name: | Smooth or threaded metallic bone fixation fastener. |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 888.3040 |
MBI Product Code:
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Image /page/5/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font.
Image /page/5/Picture/1 description: The image shows the logo for Healthium. The logo consists of the word "Healthium" in a dark blue, sans-serif font. To the right of the word is a graphic of two overlapping circles, one orange and one blue, with a white plus sign in the center.
1.3. Predicate Devices:
Table 1 - List of Predicate Devices
| Device Name | 510(k) Number | S.No | Parameters | ArthrexSuture(K143745) | CorkscrewAnchors | ArthrexSuture Anchors(K140855) | CEPTRE®KnottedUHMWPESuture PEEKAnchor(Subject Device) |
|---|---|---|---|---|---|---|---|
| Arthrex Corkscrew Suture Anchors | K143745 | 1. | Manufacturer | Arthrex, Incorporated | Arthrex, Incorporated | Arthrex, Incorporated | HealthiumMedtech Limited |
| Arthrex SutureTak Suture Anchors | K140855 | 2. | Product Code | MBI | MAI (ClassificationProduct Code)MBI (Subsequent ProductCode) | MBI | |
| 3. | RegulationNumber | 21 CFR 888.3040 | 21 CFR 888.3030 | 21 CFR 888.3040 | |||
| 4. | Classification | Class II | Class II | Class II | |||
| 5. | Intended Use | The Arthrex Corkscrewsuture anchors areintended to be used forfixation of suture (softtissue) to bone in theshoulder, foot/ankle,hip, knee, hand/wrist,and elbow in thefollowing procedures:• Shoulder: RotatorCuff Repair, BankartRepair, SLAPLesion Repair,Biceps Tenodesis,Acromio-ClavicularSeparation Repair,Deltoid Repair,Capsular Shift orCapsulolabralReconstruction.• Foot/Ankle:LateralStabilization,MedialStabilization,AchillesTendon Repair,Hallux ValgusReconstruction,Mid-footReconstruction,MetatarsalLigamentRepair/TendonRepair andBunionectomy. | The Arthrex SutureTaksuture anchors areintended to be used forsuture (soft tissue)fixation to bone in thefoot, ankle, knee, hand,wrist, elbow, shoulder,and hip.• Shoulder: Rotator CuffRepair, Bankart Repair,SLAP Lesion Repair,Biceps Tenodesis,Acromio-ClabicularSeparation Repair,Deltoid Repair,Capsular Shift orCapsulolabralReconstruction• Foot/Ankle: LateralStabilization, MedialStabilization, AchillesTendon Repair,Metatarsal LigamentRepair, Hallux Valgusreconstruction, digitaltendon transfers, Mid-foot reconstruction• Knee: Medial CollateralLigament Repair,Lateral CollateralLigament Repair,Patellar Tendon Repair,Posterior ObliqueLigament Repair,Iliotibial BandTenodesis | The CEPTRE®KnottedUHMWPE SuturePEEK Anchor areindicated insurgicalprocedures for softtissue fixation tobone in the foot,ankle, knee, hand,wrist, elbow,shoulder and hipfor the followingindications:1. Shoulder:Rotator CuffRepair,BankartRepair, SLAPLesion Repair,BicepsTenodesis,Acromio-ClavicularSeparationRepair,Deltoid RepairCapsular ShiftorCapsulolabralReconstruction• 2. Foot/Ankle:LateralStabilization,Medialstabilization |
Device Description 1.4.
The CEPTRE® Knotted UHMWPE Suture PEEK Anchors are available as Screw Anchor (threaded) & Wedge Anchor (Tap in) which are preloaded with suture(s), tape(s) or suture-tape combinations on a disposable inserter assembly. The implant is supplied sterile and ready to use.
1.5. Indications for Use
Indications for Use
The CEPTRE® Knotted UHMWPE Suture PEEK Anchor are indicated in surgical procedures for soft tissue fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder and hip for the following indications:
- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, 1. Acromio-Clavicular Separation Repair, Deltoid Repair Capsular Shift or Capsulolabral Reconstruction.
- Foot/Ankle: Lateral Stabilization. Medial stabilization. Achilles Tendon repair. Hallux Valgus 2. reconstruction, Mid-foot reconstruction, Metatarsal ligament repair, Digital tendon transfers and Bunionectomy
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral ligament repair, Lateral collateral 3. ligament repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Iliotibial band tenodesis.
-
- Hand/Wrist: Scapholunate ligament reconstruction. Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital tendon transfers.
- న్. Elbow: Biceps tendon reattachment, Tennis Elbow Repair, Ulnar or Radial collateral ligament reconstruction, and lateral Epicondylitis repair.
- Hip: Acetabular labral repair, Capsular repair and gluteus medius repair. 6.
1.6. Comparison of Technological Characteristics
The fundamental scientific technology, materials of construction and mechanism of operation are similar between the subject device CEPTRE® Knotted UHMWPE Suture PEEK Anchor and the predicate devices. Table 2 summarizes the comparison of technological characteristics between the subject and predicate device.
Table 2 - Substantial Equivalence Table
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Image /page/6/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" replaced by a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, lighter font.
Image /page/6/Picture/1 description: The image contains the word "Healthium" in a blue, sans-serif font. To the right of the word is a graphic consisting of two overlapping circles. The bottom circle is blue, and the top circle is orange.
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Image /page/7/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "Sironix" is in a bold, sans-serif font, with the "O" in "Sironix" being a red circle. Below "Sironix" is the text "Arthroscopy Solutions" in a smaller, sans-serif font.
Image /page/7/Picture/1 description: The image shows the logo for Healthium. The logo consists of the word "Healthium" in a blue, sans-serif font. To the right of the word is a graphic of two overlapping circles, one blue and one orange. The blue circle is in the foreground and the orange circle is in the background.
| S.No | Parameters | ArthrexSuture(K143745) | CorkscrewAnchors | ArthrexSuture Anchors(K140855) | SutureTakCEPTRE®KnottedUHMWPESuture PEEKAnchor(Subject Device) | |
|---|---|---|---|---|---|---|
| Knee: AnteriorCruciate LigamentRepair, MedialCollateralLigament Repair,Lateral CollateralLigament Repair,Patellar TendonRepair, PosteriorOblique LigamentRepair, andIlliotibial BandTenodesis. Hand/Wrist:ScapholunateLigamentReconstruction,Ulnar or RadialCollateralLigamentReconstruction. Elbow: BicepsTendonReattachment,Tennis ElbowRepair, Ulnaror RadialCollateralLigamentReconstruction,LateralEpicondylitisrepair. Hip: Capsularrepair,acetabularlabral repair,gluteus mediusrepair. | Hand/Wrist:ScapholunateLigamentReconstruction,Carpal LigamentReconstruction,Repair/Reconstructionof collateralligaments, Repair ofFlexor and ExtensorTendons at the PIP,DIP, and MCP jointsfor all digits, digitaltendon transfers Elbow: BicepsTendon Reattachment,Ulnar or RadialCollateral LigamentReconstruction Hip: Capsular repair,Acetabular Labralrepair | AchillesTendon repair,Hallux Valgusreconstruction,Mid-footreconstruction,Metatarsalligamentrepair/tendonrepair, Digitaltendontransfers andBunionectomy3. Knee: AnteriorCruciateLigamentRepair, MedialCollateralligamentrepair, Lateralcollateralligamentrepair, PatellarTendonRepair,PosteriorObliqueLigamentRepair andIliotibial bandtenodesis.4. Hand/Wrist:Scapholunateligamentreconstruction,Ulnar orRadialCollateralLigamentReconstruction, CarpalLigamentReconstruction,Repair/Reconstruction ofcollateralligaments, | ||||
| S.No | Parameters | ArthrexSuture(K143745) | CorkscrewAnchors | ArthrexSuture Anchors(K140855) | CEPTRE®KnottedUHMWPESuture PEEKAnchor(Subject Device) | |
| 6. | AnchorMaterial | PEEK | PEEK | PEEK | PEEK | |
| 7. | Suture / TapeMaterial | UHWMPEorapolyblendofUHMWPEandpolyester | UHWMPE or a polyblendof UHWMPE andpolyester | Suture-UHMWPEUSP#2Tape- UHMWPE1.5mm Round-Flat-Round | ||
| 8. | DesignFeature | The Arthrex Corkscrewis fully threaded sutureanchorsdesigned for maximumfixation strength andsimpleinsertion. An internaldrive mechanism iscombined witha unique eyelet to allowfor continuous | The SutureTak SutureAnchors are threadedmade up of PEEKmaterial, designed formaximum fixationstrength.The implant is providedpreloaded on an inserterand may include eyeletswhich are preloaded withvarious types of suture, | Repair ofFlexor andExtensorTendons at thePIP, DIP, andMCP joints forall digits,Digital tendontransfers.5. Elbow: Bicepstendonreattachment,Tennis ElbowRepair, Ulnaror Radialcollateralligamentreconstruction,and lateralEpicondylitisrepair.6. Hip:Acetabularlabral repair,Capsular repairand gluteusmedius repair. | ||
| with the suture(s),tape(s) or suture-tape combinations | ||||||
| S.No | Parameters | ArthrexSuture(K143745) | CorkscrewAnchors | Arthrex Suture Anchors(K140855) | SutureTak | CEPTRE®KnottedUHMWPESuture PEEKAnchor(Subject Device) |
| threads along the entirelength of the anchor.The anchorsare loaded withFiberWire sutures ortapes to providesuperior repair strength. | made up ofUHMWPE on thedisposable SterileInserters. | |||||
| 9. | SpecificationsandDimensions | PEEKCorkscrew FTSuture Anchor,4.5 mm x 14mm w/two #2FiberWire (1Blue, 1White/Black) PEEKCorkscrew FTSuture Anchor,4.75 mm x 14mm w/two 1.3mmSutureTapes(White/Black,White/Blue) PEEKCorkscrew FTSuture Anchor,4.75 mm x 14mm w/two 1.3mmSutureTapes(White/Black,White/Blue) PEEKCorkscrew FTSuture Anchor,5.5 mm x 14.7mm w/three #2FiberWire | SutureTak SutureAnchor 2mm x12mm #1FiberWire SutureTak SutureAnchor 2.4 mm x12mm #2FiberWire SutureTak SutureAnchor 3 mm x14mm #2Fiber Wire SutureTak SutureAnchor 3 mm x14mm #2FiberWire, qty. 2 | Wedge anchor:USP #2 SutureLoaded-2.5mm, Length12mm USP #2 DoubleSuturesLoaded-2.8mm, Length12mm 1.5mm DoubleTapes Loaded-2.8mm, Length12mm Screw anchor:USP #2 Suture& 1.5mm TapeLoaded-4.8mm, Length15mm USP #2 DoubleSuturesLoaded-4.8mm, Length15mm 1.5mm DoubleTapes Loaded-4.8mm, Length15mm USP #2 Suture&1.5mm TapeLoaded-5.5mm, Length15mm USP #2 DoubleSuturesLoaded-5.5mm, Length15mm | ||
| S.No | Parameters | ArthrexSuture(K143745) | CorkscrewAnchors | ArthrexSuture Anchors(K140855) | CEPTRE®KnottedUHMWPESuture PEEKAnchor(Subject Device) | |
| PEEKCorkscrew FTSuture Anchor,6.5 mm x 14.7mm w/two #2FiberWire | 1.5mm DoubleTapes Loaded-5.5mm, Length15mm USP #2 TripleSuturesLoaded-5.5mm, Length15mm | |||||
| 10 | SingleUse/Reuse | Single Use | Single Use | Single Use | ||
| 11 | Shelf Life | 5 Years | 5 Years | 5 Years | ||
| 12 | SterilizationMethod | EtO | EtO | EtO | ||
| 13 | PerformanceData | Insertion testing, Staticpull-out Testing,Fatigue testing | Tensile testingFatigue testing | Drive In TorquePull-Out TestCyclical Loading | ||
| 14 | Safety Data | No Data Available | No Data Available | SkinSensitization Intracutaneousreactivity MaterialMediatedPyrogenicity Acute SystemicToxicity In vitrocytotoxicity BoneImplantation MuscleImplantation BacterialEndotoxin |
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Image /page/8/Picture/0 description: The image shows the logo for Sironix. The word "Sironix" is written in a sans-serif font, with the "O" in "Sironix" being a red circle. Below the word "Sironix" is the phrase "Arthroscopy Solutions" in a smaller font.
Image /page/8/Picture/1 description: The image shows the logo for Healthium. The word "Healthium" is written in a blue, sans-serif font. To the right of the word is a graphic of two overlapping circles, one blue and one orange, with a white plus sign in the center.
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Image /page/9/Picture/0 description: The image shows the logo for Sironix. The word "Sironix" is written in a sans-serif font, with the "O" in "Sironix" being a red circle. Below the word "Sironix" is the phrase "Arthroscopy Solutions" in a smaller font.
Image /page/9/Picture/1 description: The image shows the logo for Healthium. The word "Healthium" is written in blue, with the "H" capitalized. To the right of the word is a graphic of two overlapping circles, one blue and one orange. The blue circle has a white plus sign in the middle.
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Image /page/10/Picture/0 description: The image shows the logo for Sironix. The word "SIRONIX" is written in a sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the text "ArthroscopySolutions" in a smaller font.
Image /page/10/Picture/1 description: The image shows the logo for Healthium. The logo consists of the word "Healthium" in a dark blue, sans-serif font. To the right of the word is a graphic consisting of two overlapping circles, one orange and one blue. A white plus sign is visible in the blue circle.
1.7. Summary of Performance Data
The CEPTRE® Knotted UHMWPE Suture PEEK Anchor and Predicate device underwent tests to determine their pull-out strength, cyclical loading and drive in torque test. Results demonstrated that the CEPTRE® Knotted UHMWPE Suture PEEK Anchor performs statistically equivalent to the predicate device.
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Image /page/11/Picture/1 description: The image shows the logo for Healthium. The logo consists of the word "Healthium" in a dark blue, sans-serif font. To the right of the word is a graphic consisting of two overlapping circles, one orange and one dark blue. A white plus sign is superimposed over the circles.
1.8. Non-Clinical Testing
The Static pull out testing and cyclic loading were performed on the subject device to demonstrate that the differences do not negatively impact mechanical strength.
Bacterial endotoxin per USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications.
Packaging testing was conducted to demonstrate shelf-life and confirm the packaging design provides a protective sterile barrier and protects the integrity of the products post sterilization during shipping and handling.
1.9. Conclusion
There are no significant differences between the subject device and the predicate devices that would adversely affect the use of the product. The subject device is substantially equivalent to the predicate devices (Arthrex Corkscrew Suture Anchors and Arthrex SutureTak Suture Anchors) in design, Intended use, Indications for use, function, Sterilization method, Shelf Life, and operational principles. From the data available we can justify that the CEPTRE® Knotted UHMWPE Suture PEEK Anchor is as safe, and as effective and performs the same indications for use as that of already marketed predicate device identified.
§ 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.