(30 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and sterilization of a physical implantable anchor, with no mention of software, algorithms, or data processing related to AI/ML.
Yes
The device is permanently implanted into the body to reattach soft tissue to bone, which constitutes a therapeutic intervention aimed at restoring function and promoting healing.
No
The device is an anchor used for reattachment of soft tissue to bone, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states that the device consists of physical components (threaded anchor, dilator, inserter shaft, handle, stay suture) that are permanently implanted into the body. It is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure for reattaching soft tissue to bone in specific anatomical locations (shoulder, knee, foot/ankle). This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is described as a permanently implanted anchor made of PEEK or Biocomposite material, used to secure soft tissue to bone. This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body as a surgical implant.
N/A
Intended Use / Indications for Use
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)
Product codes (comma separated list FDA assigned to the subject device)
MBI, MAI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Knee, Foot/Ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Verification activities were performed on the proposed device and its predicates. 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.
Ethylene Oxide Sterilization was validated according to ANSI/AAMI/ISO 11135: 2014 to a SAL of 1 x 10^-6.
EO residuals were tested per AAMI/ANSI/ISO 10993-7:2008
The proposed device has been determined to be non-pyrogenic per the requirements set forth in ANSI/AAMI ST-72:2011, United States Pharmacopeia (USP), and European Pharmacopeia (EP) using the bacterial endotoxin testing (BET) method.
Results of performance testing have demonstrated that the proposed devices are suitable for their intended use.
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
§ 888.3040 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.
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August 7, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol representing the Department of Health & Human Services-USA on the left, and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The text is in a sans-serif font, with "FDA" in a blue square and the rest of the text in blue as well.
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
1
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's
Name and
Address | DePuy Synthes Mitek Sports Medicine
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767
On behalf of:
Medos International SARL
Chemin-Blanc 38, Le Locle Neuchatel
CH 2400, Switzerland | Substantial
Equivalence | The HEALIX ADVANCE SP PEEK Anchor is substantially equivalent
to:
• K182941, HEALIX ADVANCE SP PEEK Anchor
The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is
substantially equivalent to:
• K191242, HEALIX ADVANCE SP BIOCOMPOSITE Anchor |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Elizabeth Messana
Regulatory Affairs Specialist II
Telephone: 508-828-3150
Email: emessan1@its.jnj.com
DePuy Synthes Mitek Sports Medicine
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 | Device
Classification | 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 and
accessories, classified as Class II, product code MAI, regulated under
21 CFR 888.3030. |
| Name of Medical
Device | Proprietary Name:
A) HEALIX ADVANCE™ SP PEEK Anchor
B) HEALIX ADVANCE™ SP BIOCOMPOSITE Anchor
Classification Name:
A) Smooth or threaded metallic bone fixation fastener
B) Single/multiple component metallic bone fixation appliances
and accessories
Product Code:
A) MBI
B) MAI
Common Name:
Suture Anchor | Device Panel | Orthopedic Devices |
| Device
Description | 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. | | |
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5
| Technological
Characteristics | The suture anchor design, principal of operation and indications for use
are identical when compared to the predicate device- HEALIX
ADVANCE™ SP PEEK Anchor (K182941).
The suture anchor design and principal of operation are identical when
compared to the predicate device- HEALIX ADVANCE™ SP
BIOCOMPOSITE Anchor (K191242), and similar in terms of
indications for use (a subset is pursued). |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The HEALIX ADVANCE SP PEEK Anchor is indicated for use 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 collateral 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
• 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-clinical
Testing | Verification activities were performed on the proposed device and its
predicates. 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.
Ethylene Oxide Sterilization was validated according to
ANSI/AAMI/ISO 11135: 2014 to a SAL of 1 x 10-6.
EO residuals were tested per AAMI/ANSI/ISO 10993-7:2008
The proposed device has been determined to be non-pyrogenic per the
requirements set forth in ANSI/AAMI ST-72:2011, United States
Pharmacopeia (USP), and European Pharmacopeia (EP) using the
bacterial endotoxin testing (BET) method. |
| Safety and
Performance | Results of performance testing have demonstrated that the proposed
devices are suitable for their intended use. |
| | Based on similarities in the indications for use, technological
characteristics, and performance in comparison to the predicate devices,
the proposed HEALIX ADVANCE SP PEEK Anchor and HEALIX
ADVANCE SP BIOCOMPOSITE Anchor has shown to be
substantially equivalent to the predicate devices under the Federal Food,
Drug and Cosmetic Act. |
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