(30 days)
The HEALIX ADVANCE SP PEEK Anchor is in the following procedures for reattachment of soft tissue to bone:
Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair
- Knee: Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral ligament reconstruction, iliotibial (IT) band tenodesis
Foot/Ankle: Achilles tendon repair
The HEALIX ADVANCE SP Biocomposite Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone:
Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair
- Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral ligament Knee: reconstruction, iliotibial (IT) band tenodesis
- Foot/Ankle: Achilles tendon repair (4.9mm & 5.5mm only)
The proposed HEALIX ADVANCE SP PEEK and BIOCOMPOSITE Anchors is a line extension to the currently marketed HEALIX ADVANCE SP Anchor family. Both versions of the device consist of a two-piece "self-punching" design consisting of a cannulated, threaded anchor (PEEK or BIOCOMPOSITE) and PEEK (Polyetheretherketone) dilator which are permanently implanted into the body. The anchor- dilator are preloaded on a disposable inserter shaft with handle, held in place by a non-absorbable stay suture comprised of Ultra-High Molecular Weight Polyethylene (UHMWPE) and Green poly (ethylene terephthalate) (PET). Following anchor-dilator implantation, the stay suture is discarded.
The proposed HEALIX ADVANCE SP PEEK and BIOCOMPOSITE Anchors will be available in a new size option, 6.5 mm, molded from either Polyetheretherketone (PEEK) material or Absorbable Biocryl Biocomposite ((Polylactic Acid (PLA) and Tricalcium Phosphate (TCP)) material.
Both the HEALIX ADVANCE SP PEEK Anchor and HEALIX ADVANCE SP BIOCOMPOSITE Anchor are provided sterile via Ethylene Oxide (EO) sterilization and are for single use only.
This FDA 510(k) summary describes a medical device, the HEALIX ADVANCE™ SP PEEK Anchor and HEALIX ADVANCE™ SP BIOCOMPOSITE Anchor. It is a submission for substantial equivalence to previously cleared devices, making it a "line extension." Therefore, the document focuses on demonstrating that the new devices are as safe and effective as the predicate devices, rather than establishing de novo acceptance criteria for an entirely new technology using a clinical study.
Here's an analysis based on the provided text, addressing your questions where applicable:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence submission for a line extension of an existing product, the "acceptance criteria" are implicitly met by demonstrating that the new device performs equivalently to the predicate devices in specific non-clinical tests. The document doesn't provide explicit numerical acceptance criteria values that the device had to meet (e.g., "pull-out strength must be > X N"). Instead, it states that "Performance testing included evaluation of in-vitro fixation strength at zero, six and twelve weeks, insertion torque, torque to failure and cyclic migration at time zero." and concludes that "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use."
The comparison is made against the predicate devices (K182941 for PEEK and K191242 for BIOCOMPOSITE). The core assertion is that the new 6.5mm size options perform comparably to the already cleared sizes and materials.
Implicit Acceptance Criteria and Reported Performance (derived from text):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent in-vitro fixation strength at 0, 6, 12 weeks to predicate | Demonstrated to be suitable for intended use, comparable to predicate devices. |
| Equivalent insertion torque to predicate | Demonstrated to be suitable for intended use, comparable to predicate devices. |
| Equivalent torque to failure to predicate | Demonstrated to be suitable for intended use, comparable to predicate devices. |
| Equivalent cyclic migration at time zero to predicate | Demonstrated to be suitable for intended use, comparable to predicate devices. |
| Sterilization validated to ANSI/AAMI/ISO 11135: 2014 (SAL of 1 x 10-6) | Validation confirmed. |
| EO residuals tested per AAMI/ANSI/ISO 10993-7:2008 | Testing confirmed. |
| Non-pyrogenic per ANSI/AAMI ST-72:2011, USP, EP | Confirmed (using bacterial endotoxin testing (BET) method). |
| Comparable indications for use and technological characteristics to predicate devices | Similar indications and identical design/principle of operation for PEEK anchor; similar design/principle and subset of indications for BIOCOMPOSITE anchor. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical testing, not human clinical trials. Therefore, the "test set" refers to the samples of the devices used in the mechanical and biocompatibility tests. The specific number of devices (sample size) used for each test (e.g., how many anchors were tested for pull-out strength) is not specified in this summary.
Data Provenance: The data is from "verification activities" and "performance testing" conducted by the manufacturer, DePuy Synthes Mitek, a Johnson & Johnson company. It's retrospective in the sense that it's data collected to support the submission, but it's not retrospective patient data. It's lab-generated, in-vitro test data. The country of origin of the data is implied to be where the testing was performed, likely the United States (where DePuy Synthes Mitek is located) or Switzerland (Medos International SARL).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This question is not applicable. For a device like a suture anchor, "ground truth" in the context of clinical outcomes would typically be established in a clinical trial by expert clinicians (e.g., orthopedic surgeons) evaluating patient outcomes, or by pathology reports. However, for a 510(k) submission based on non-clinical testing for substantial equivalence, such expert-established ground truth for a "test set" (meaning patient data) is not relevant or described. The "ground truth" for the non-clinical tests is the measured physical properties of the device.
4. Adjudication Method for the Test Set:
This question is not applicable for non-clinical, in-vitro testing. Adjudication methods (like 2+1, 3+1) are used in clinical studies or evaluations of imaging/diagnostic devices where multiple expert interpretations need to be reconciled to establish a consensus ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where the performance of human readers with and without AI assistance is evaluated across multiple cases. The device in question is a physical surgical implant, not a diagnostic tool requiring human interpretation of medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, this question is not applicable. This device is a physical implant, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.
7. The Type of Ground Truth Used:
For this device, the "ground truth" is based on objective physical measurements from in-vitro mechanical tests (fixation strength, torque, cyclic migration) and validated sterilization/biocompatibility testing against established standards (e.g., ANSI/AAMI/ISO, USP, EP). There is no pathology, outcomes data, or expert consensus (in the sense of clinical decision-making) used for "ground truth" in this 510(k) summary as it is focused on demonstrating substantial equivalence through non-clinical means.
8. The Sample Size for the Training Set:
This question is not applicable. There is no "training set" in the context of this device. Training sets are used for machine learning or AI algorithms, which this device is not.
9. How the Ground Truth for the Training Set was Established:
This question is not applicable as there is no training set for this device.
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August 7, 2020
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Medos International SARL % Elizabeth Messana Regulatory Affairs Specialist II DePuy Synthes Mitek, a Johnson and Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767
Re: K201883
Trade/Device Name: 6.5 mm HEALIX ADVANCE™ SP PEEK Anchor, 6.5 mm HEALIX ADVANCE™ SP BIOCOMPOSITE Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI, MAI Dated: July 7, 2020 Received: July 8, 2020
Dear Elizabeth Messana:
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. 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 located 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.
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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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,
for
Laura C. Rose, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201883
Device Name
HEALIX ADVANCE™ SP PEEK Anchor HEALIX ADVANCE™ SP Biocomposite Anchor
Indications for Use (Describe)
The HEALIX ADVANCE SP PEEK Anchor is in the following procedures for reattachment of soft tissue to bone:
Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair
- Knee: Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral ligament reconstruction, iliotibial (IT) band tenodesis
Foot/Ankle: Achilles tendon repair
The HEALIX ADVANCE SP Biocomposite Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone:
Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair
- Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral ligament Knee: reconstruction, iliotibial (IT) band tenodesis
- Foot/Ankle: Achilles tendon repair (4.9mm & 5.5mm only)
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)
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510(K) SUMMARY HEALIX ADVANCE™ SP Anchor Date Prepared: 07/02/2020
| Submitter'sName andAddress | DePuy Synthes Mitek Sports Medicinea Johnson & Johnson company325 Paramount DriveRaynham, MA 02767On behalf of:Medos International SARLChemin-Blanc 38, Le Locle NeuchatelCH 2400, Switzerland | SubstantialEquivalence | The HEALIX ADVANCE SP PEEK Anchor is substantially equivalentto:• K182941, HEALIX ADVANCE SP PEEK AnchorThe HEALIX ADVANCE SP BIOCOMPOSITE Anchor issubstantially equivalent to:• K191242, HEALIX ADVANCE SP BIOCOMPOSITE Anchor |
|---|---|---|---|
| Contact Person | Elizabeth MessanaRegulatory Affairs Specialist IITelephone: 508-828-3150Email: emessan1@its.jnj.comDePuy Synthes Mitek Sports Medicinea Johnson & Johnson company325 Paramount DriveRaynham, MA 02767 | DeviceClassification | HEALIX ADVANCE SP PEEK Anchor is classified as:Fastener, Fixation, Nondegradable, Soft Tissue, classified as Class II,product code MBI, regulated under 21 CFR 888.3040.HEALIX ADVANCE SP BIOCOMPOSITE Anchor is classified as:Single/multiple component metallic bone fixation appliances andaccessories, classified as Class II, product code MAI, regulated under21 CFR 888.3030. |
| Name of MedicalDevice | Proprietary Name:A) HEALIX ADVANCE™ SP PEEK AnchorB) HEALIX ADVANCE™ SP BIOCOMPOSITE AnchorClassification Name:A) Smooth or threaded metallic bone fixation fastenerB) Single/multiple component metallic bone fixation appliancesand accessoriesProduct Code:A) MBIB) MAICommon Name:Suture Anchor | Device Panel | Orthopedic Devices |
| DeviceDescription | The proposed HEALIX ADVANCE SP PEEK and BIOCOMPOSITEAnchors is a line extension to the currently marketed HEALIXADVANCE SP Anchor family. Both versions of the device consist of atwo-piece "self-punching" design consisting of a cannulated, threadedanchor (PEEK or BIOCOMPOSITE) and PEEK (Polyetheretherketone)dilator which are permanently implanted into the body. The anchor-dilator are preloaded on a disposable inserter shaft with handle, held inplace by a non-absorbable stay suture comprised of Ultra-HighMolecular Weight Polyethylene (UHMWPE) and Green poly (ethyleneterephthalate) (PET). Following anchor-dilator implantation, the staysuture is discarded.The proposed HEALIX ADVANCE SP PEEK and BIOCOMPOSITEAnchors will be available in a new size option, 6.5 mm, molded fromeither Polyetheretherketone (PEEK) material or Absorbable BiocrylBiocomposite ((Polylactic Acid (PLA) and Tricalcium Phosphate(TCP)) material.Both the HEALIX ADVANCE SP PEEK Anchor and HEALIXADVANCE SP BIOCOMPOSITE Anchor are provided sterile viaEthylene Oxide (EO) sterilization and are for single use only. |
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| TechnologicalCharacteristics | The suture anchor design, principal of operation and indications for useare identical when compared to the predicate device- HEALIXADVANCE™ SP PEEK Anchor (K182941).The suture anchor design and principal of operation are identical whencompared to the predicate device- HEALIX ADVANCE™ SPBIOCOMPOSITE Anchor (K191242), and similar in terms ofindications for use (a subset is pursued). |
|---|---|
| Indications forUse | The HEALIX ADVANCE SP PEEK Anchor is indicated for use in thefollowing procedures for reattachment of soft tissue to bone:• Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair• Knee: Posterior oblique repair, medial collateral ligament (MCL)reconstruction, lateral collateral ligament reconstruction, iliotibial(IT) band tenodesis• Foot/Ankle: Achilles tendon repairThe HEALIX ADVANCE SP BIOCOMPOSITE Anchor is indicatedfor use in the following procedures for reattachment of soft tissue tobone:• Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair• Knee: Posterior oblique repair, medial collateral ligament (MCL)reconstruction, lateral collateral ligament reconstruction, iliotibial(IT) band tenodesis• Foot/Ankle: Achilles tendon repair (4.9mm & 5.5mm only) |
| Non-clinicalTesting | Verification activities were performed on the proposed device and itspredicates. Performance testing included evaluation of in-vitro fixationstrength at zero, six and twelve weeks, insertion torque, torque to failureand cyclic migration at time zero.Ethylene Oxide Sterilization was validated according toANSI/AAMI/ISO 11135: 2014 to a SAL of 1 x 10-6.EO residuals were tested per AAMI/ANSI/ISO 10993-7:2008The proposed device has been determined to be non-pyrogenic per therequirements set forth in ANSI/AAMI ST-72:2011, United StatesPharmacopeia (USP), and European Pharmacopeia (EP) using thebacterial endotoxin testing (BET) method. |
| Safety andPerformance | Results of performance testing have demonstrated that the proposeddevices are suitable for their intended use. |
| Based on similarities in the indications for use, technologicalcharacteristics, and performance in comparison to the predicate devices,the proposed HEALIX ADVANCE SP PEEK Anchor and HEALIXADVANCE SP BIOCOMPOSITE Anchor has shown to besubstantially equivalent to the predicate devices under the Federal Food,Drug and Cosmetic Act. |
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§ 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.