(27 days)
No
The device description and intended use are focused on the mechanical properties and surgical application of suture anchors, with no mention of AI or ML.
Yes
The device is described as "suture anchors" intended for "soft tissue fixation during general orthopedic surgery" for "tendon and ligament repairs." These repairs are therapeutic interventions.
No
The devices described are suture anchors intended for soft tissue fixation during orthopedic surgery (tendon and ligament repairs). They are used for physical repair, not for diagnosing conditions or diseases.
No
The device description clearly states that the devices are physical suture anchors made from materials like PEEK and Titanium, intended for surgical implantation.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The descriptions and intended uses clearly state that these devices are suture anchors used for soft tissue fixation during general orthopedic surgery. They are implanted into the body to attach soft tissue and ligaments to bone.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, providing diagnostic information based on laboratory tests, or any other activity associated with in vitro diagnostics.
These devices are implantable surgical devices used for mechanical fixation within the body, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
VersaTap™ Suture Anchor
The VersaTap™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaTap™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
- Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus
- Elbow: Tennis elbow repair
- Knee: Medial and lateral collateral ligament repair.
- Wrist: Scapholunate ligament reconstruction
VersaPEEK™ Suture Anchor
The VersaPEEK™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaPEEK™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
- Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus
- Elbow: Tennis elbow repair
- Knee: Medial and lateral collateral ligament repair.
- Wrist: Scapholunate ligament reconstruction
MicroTi™ Suture Anchor
The MicroTi™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The MicroTi™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
- Elbow: Ulnar/Medial Collateral Ligament Repair
- Foot/Ankle: Achilles Tendon Repair, Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-foot Reconstruction, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
- Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction.
VersaLat™ Ti Suture Anchor
The VersaLat™ Ti Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/ healthy tissue during tendon and ligament repairs, during procedures such as:
- Shoulder: Rotator Cuff Repair, Biceps Tenodesis
- Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collament Ligament Reconstruction.
- Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Iliotibial Band Tenodesis
- Foot/Ankle: Lateral stabilization, medial stabilization, Achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, metatarsal tendon repair, bunionectomy, and digital tendon transfers.
VersaLat™ Suture Anchor
The VersaLat™ Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/ healthy tissue during tendon and ligament repairs, during procedures such as:
- Shoulder: Rotator Cuff Repair, Biceps Tenodesis
- Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction.
- Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Illiotibial Band Tenodesis.
- Foot/Ankle: Lateral stabilization, medial stabilization, Achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, metatarsal tendon repair, bunionectomy, and digital tendon transfers.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
VersaTap™ Suture Anchor
The VersaTap™ Suture Anchor is a self-tapping suture anchor. This anchor is designed to combine the advantages of both PEEK and Titanium. The titanium tip makes the product self-tapping, whilst the majority of the anchor is manufactured from PEEK to minimize post-operative imaging effects.
VersaPEEK™ Suture Anchor
The VersaPEEK™ Suture Anchor is manufactured completely from PEEK. This material composition minimizes post-operative imaging effects. The suture anchor is designed for ultimate mechanical properties (pullout strength, tensile strength, etc). The VersaPEEK™ Suture Anchor also has a variety of suture/suture tape configurations.
MicroTi™ Suture Anchor
The MicroTi™ Suture Anchor is a small screw-in suture anchor used in a variety of small-joint applications. Despite its small diameter, the specially engineered thread combines with cortical bone to provide tremendous pull-out strength.
VersaLat™ Ti Suture Anchor
The VersaLat™ Ti Suture Anchor is a knotless-/suture anchor. This titanium screw-in anchor can be combined with the VersaTap™ Suture Anchor in double rotator cuff repair surgery. Flexibility is what differentiates this anchor from its competitors with surgeons being able to fixate any number of sutures/tapes (K150438) by adjusting the size of the characteristic front loop. The extra suture provided by this anchor can also be used for the fixation of the biceps tendon or any ligament fragments.
VersaLat™ Suture Anchor
The VersaLat™ Suture Anchor is a knotless-/suture anchor. This titanium screw-in anchor can be combined with the VersaTap™ Suture Anchor in double rotator cuff repair surgery. Flexibility is what differentiates this anchor from its competitors with surgeons being able to fixate any number of sutures/tapes (K150438) by adjusting the size of the characteristic front loop. The extra suture provided by this anchor can also be used for the fixation of the biceps tendon or any ligament fragments.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Elbow, Knee, Wrist, Hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
General orthopedic surgery / arthroscopic or open surgical approaches
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)
Substantial equivalence is supported by the results of mechanical testing including insertion torque and static pullout testing, and by justification for dynamic pullout (fatigue), component interconnection, and corrosion testing according to the FDA Guidance: 'Bone Anchors - Premarket Notification (510(k)) Submissions'. Ortho-Design's suture anchors support safety and effectiveness and can be considered substantially equivalent to the predicate device (cleared in K212381).
The subject devices have been tested to be non-pyrogenic.
The subject device demonstrates substantial equivalence by non-clinical testing consisting of mechanical, biocompatibility, sterility, shelf-life, packaging and pyrogenicity tests and adheres to the minimum requirements set out in FDA's guidance document for Bone Anchors – Premarket Notification (510(k)) Submissions.
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.
K070908, K061665, K173788, K063453, K130274, K070758, K071257, K111000, K200523, K151342, K190728, K203495
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
August 29, 2024
Ortho-Design (Pty) Ltd Dian Peach Managing Director 17 Dely Road Hazelwood, Pretoria 0081 South Africa
Re: K242296
VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); Trade/Device Name: MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLatTM Suture Anchor (ADP021-PK) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: May 3, 2024
Dear Dian Peach:
Received: August 2, 2024
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/cdrb/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"
1
(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 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 (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/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-devices/medical-device-safety/medical-device-reporting-mdr-how-reportmedical-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/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Christopher Ferreira -S
Christopher Ferreira, MS Assistant Director, Biomedical Engineer 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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
VersaTap TM Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK)
Indications for Use (Describe)
VersaTap™ Suture Anchor
The VersaTap™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaTap™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
- · Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair
- · Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus
- · Elbow: Tennis elbow repair
- · Knee: Medial and lateral collateral ligament repair.
- · Wrist: Scapholunate ligament reconstruction
VersaPEEK™ Suture Anchor
The VersaPEEK™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaPEEK™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
- · Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair
- · Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus
- · Elbow: Tennis elbow repair
- · Knee: Medial and lateral collateral ligament repair.
- · Wrist: Scapholunate ligament reconstruction
MicroTi™ Suture Anchor
The MicroTi™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The MicroTi™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
- · Elbow: Ulnar/Medial Collateral Ligament Repair
· Foot/Ankle: Achilles Tendon Repair, Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-foot Reconstruction, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
· Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction.
3
VersaLat™ Ti Suture Anchor
The VersaLat™ Ti Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/ healthy tissue during tendon and ligament repairs, during procedures such as:
· Shoulder: Rotator Cuff Repair, Biceps Tenodesis
· Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction.
· Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Iliotibial Band Tenodesis
· Foot/Ankle: Lateral stabilization, medial stabilization, Achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, metatarsal tendon repair, bunionectomy, and digital tendon transfers.
VersaLat™ Suture Anchor
The VersaLat™ Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/ healthy tissue during tendon and ligament repairs, during procedures such as:
- · Shoulder: Rotator Cuff Repair, Biceps Tenodesis
- · Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction.
· Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Illiotibial Band Tenodesis.
· Foot/Ankle: Lateral stabilization, medial stabilization, Achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, metatarsal tendon repair, bunionectomy, and digital tendon transfers.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
510(k) SUMMARY
The following information is provided in accordance with 21CFR 807.92 for the Premarket 510(k) Summary:
| Submitter Information: | Ortho-Design (Pty) Ltd
17 Dely Road
Hazelwood, Pretoria, 0081 South
Africa |
|-----------------------------------------|-------------------------------------------------------------------------------------|
| Date: | 26 August 2024 |
| Contact Person:
Telephone:
Email: | Dian Peach, Managing Director
(+27) 12 807 1902
dianpeach@ortho-design.co.za |
Table 1: Subject devices and their respective submission K212381 predicate devices.
| K212381 | The enclosed submission |
|---|---|
| VersaTap™ Suture Anchor | VersaTap™ Suture Anchor (Device A) |
| VersaPEEK™ Suture Anchor (Device B) | |
| MiniTi™ Suture Anchor | MicroTi™ Suture Anchor (Device C) |
| VersaLat™ Suture Anchor | VersaLat™ Ti Suture Anchor (Device D) |
| VersaLat™ Suture Anchor (Device E) |
Table 2: DEVICE A – VersaTap™ Suture Anchor
| | Subject Device | Predicate Device
(Cleared in K212381) |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | VersaTap™ Suture Anchor | VersaTap™ Suture Anchor
(Cleared in K212381) |
| Regulation Description: | Smooth or threaded metallic
bone fixation fastener. | Smooth or threaded metallic
bone fixation fastener. |
| Classification Name: | Fastener, Fixation,
Nondegradable, Soft Tissue | Fastener, Fixation,
Nondegradable, Soft Tissue |
| Regulation Number: | 21 CFR 888.3040 | 21 CFR 888.3040 |
| Device Classification: | Class II | Class II |
| Product Code: | MBI | MBI |
| Reference Device(s): | KINSA RC Suture Anchor
(K070908), manufactured by
Smith & Nephew | K061665; K173788;
K063453, K130274, K070758 |
| Device Description: | The VersaTap™ Suture
Anchor is a self-tapping suture
anchor. This anchor is
designed to combine the
advantages of both PEEK and
Titanium. The titanium tip
makes the product self-tapping,
whilst the majority of the
anchor is manufactured from
PEEK to minimize post-
operative imaging effects. | The VersaTap™ Suture
Anchor is a self-tapping
suture anchor mostly used as
a medial row anchor in
rotator cuff repair surgery.
This anchor is ingeniously
designed to combine the
advantage of both PEEK and
Titanium. The titanium tip
allows for self-tapping
ability whilst the majority of
the anchor is manufactured
from PEEK which minimizes
post-operative imaging
effects. |
| Indications for Use: | The VersaTap™ Suture Anchor
is intended to be used for soft
tissue fixation during general
orthopedic surgery. The
VersaTap™ Suture Anchor is
intended for use in arthroscopic
or open surgical approaches for
fixation of soft tissue and
ligaments to bone/healthy
tissue during tendon and
ligament repairs, during
procedures such as:
• Shoulder: Rotator cuff
repair, biceps tenodesis,
SLAP repair, Bankart
repair
• Foot/Ankle: Lateral
Stabilization, Medial
Stabilization, Achilles
Tendon Repair, Hallux
Valgus
• Elbow: Tennis elbow repair
• Knee: Medial and lateral
collateral ligament repair.
• Wrist: Scapholunate
ligament reconstruction. | The VersaTap™ Suture
Anchor is intended to be
used for soft tissue fixation
during general orthopedic
surgery. The VersaTap™
Suture Anchor is intended for
use in arthroscopic or open
surgical approaches for
fixation of soft tissue and
ligaments to bone/healthy
tissue during tendon and
ligament repairs, during
procedures such as:
• Shoulder: Rotator cuff
repair, biceps tenodesis,
SLAP repair, Bankart
repair
• Foot/Ankle: Lateral
Stabilization, Medial
Stabilization, Achilles
Tendon Repair, Hallux
Valgus
• Elbow: Tennis elbow
repair
• Knee: Medial and lateral
collateral ligament repair.
• Wrist: Scapholunate
ligament reconstruction |
| Relationship to the
Device: | The subject and predicate devices (cleared in K212381)
have the same intended use, materials,
packaging, and similar design features. | function. |
| Technological
Differences: | The subject and predicate devices (cleared in K212381) have similar engineering designs with minor dimensional changes. The subject device has a reduced diameter and a reduced length compared to the predicate device (cleared in K212381). | |
| Clinical Characteristics: | The subject and predicate devices (cleared in K212381) are intended to be used for soft tissue fixation during general orthopedic surgery. | |
| Technical Equivalence: | The subject and predicate devices (cleared in K212381) have similar designs, development methods, principles of operations and performance. | |
| Mechanical Testing and
Disclosure of
Performance and Safety
Deviation: | Substantial equivalence is supported by the results of mechanical testing including insertion torque and static pullout testing, and by justification for dynamic pullout (fatigue), component interconnection, and corrosion testing according to the FDA Guidance: 'Bone Anchors - Premarket Notification (510(k)) Submissions'. Ortho-Design's suture anchors support safety and effectiveness and can be considered substantially equivalent to the predicate device (cleared in K212381). | |
| Biocompatibility: | The subject and predicate devices (cleared in K212381) are manufactured using the same approved suppliers, manufacturing facilities, manufacturing processes, chemicals, materials, and cleaning processes. All manufacturing is conducted according to the processes defined by ISO 13485 and ISO 9001. All materials, processes, and cleaning agents used for the subject device have been used in the previously cleared device(s). Therefore biocompatibility of the subject device is substantially equivalent to the predicate device.
The subject devices have been tested to be non-pyrogenic. | |
| Quality Control
Measures | For both the subject and predicate device (cleared in K212381)
the methods, thresholds and criteria of the following are
identical:
Sterility Self-Life Packaging Pyrogenicity / Endotoxin Testing | |
| Conclusion: | The subject device demonstrates substantial equivalence by
non-clinical testing consisting of mechanical, biocompatibility,
sterility, shelf-life, packaging and pyrogenicity tests and
adheres to the minimum requirements set out in FDA's
guidance document for Bone Anchors – Premarket
Notification (510(k)) Submissions. | |
| | Subject Device | Predicate Device
(Cleared in K212381) |
| Device Trade Name: | VersaPEEK™ Suture Anchor | VersaTap™ Suture Anchor
(Cleared in K212381) |
| Regulation Description: | Smooth or threaded metallic
bone fixation fastener. | Smooth or threaded metallic
bone fixation fastener. |
| Classification Name: | Fastener, Fixation,
Nondegradable, Soft Tissue | Fastener, Fixation,
Nondegradable, Soft Tissue |
| Regulation Number: | 21 CFR 888.3040 | 21 CFR 888.3040 |
| Device Classification: | Class II | Class II |
| Product Code: | MBI | MBI |
| Reference Device(s): | KINSA RC Suture Anchor
(K070908), manufactured by
Smith & Nephew | K061665; K173788;
K063453, K130274, K070758 |
| Device Description: | The VersaPEEK™ Suture
Anchor is manufactured
completely from PEEK. This
material composition
minimizes post-operative
imaging effects. The suture
anchor is designed for ultimate
mechanical properties (pullout
strength, tensile strength, etc).
The VersaPEEK™ Suture
Anchor also has a variety of
suture/suture tape
configurations. | The VersaTap™ Suture
Anchor is a self-tapping
suture anchor mostly used as
a medial row anchor in
rotator cuff repair surgery.
This anchor is ingeniously
designed to combine the
advantage of both PEEK and
Titanium. The titanium tip
allows for self-tapping
ability whilst the majority of
the anchor is manufactured
from PEEK which minimizes
post-operative imaging
effects. |
| Indications for Use: | The VersaPEEK™ Suture
Anchor is intended to be used
for soft tissue fixation during
general orthopedic surgery.
The VersaPEEK™ Suture
Anchor is intended for use in
arthroscopic or open surgical
approaches for fixation of soft
tissue and ligaments to
bone/healthy tissue during
tendon and ligament repairs,
during procedures such as:
• Shoulder: Rotator cuff
repair, biceps tenodesis,
SLAP repair, Bankart | The VersaTap™ Suture
Anchor is intended to be
used for soft tissue fixation
during general orthopedic
surgery. The VersaTap™
Suture Anchor is intended for
use in arthroscopic or open
surgical approaches for
fixation of soft tissue and
ligaments to bone/healthy
tissue during tendon and
ligament repairs, during
procedures such as:
• Shoulder: Rotator cuff
repair, biceps tenodesis, |
| | Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Elbow: Tennis elbow repair. Knee: Medial and lateral collateral ligament repair. Wrist: Scapholunate ligament reconstruction. *The above-mentioned indications for use are identical to those of the predicate device, VersaTap™ Suture Anchor, cleared in submission K212381. | SLAP repair, Bankart repair Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Elbow: Tennis elbow repair Knee: Medial and lateral collateral ligament repair. Wrist: Scapholunate ligament reconstruction |
| Relationship to the
Device: | The subject and predicate devices (cleared in K212381) have the same intended use, materials, function, packaging, and similar design features. | |
| Technological
Differences: | The subject and predicate devices (cleared in K212381) have similar engineering designs and minor dimensional changes. The subject device has a reduced diameter compared to the predicate device (cleared in K212381). The subject device is also composed fully composed of PEEK whereas the predicate device (cleared in K212381) is composed of a PEEK body and a titanium tip. | |
| Clinical Characteristics: | The subject and predicate device (cleared in K212381) are intended to be used for soft tissue fixation during general orthopedic surgery. | |
| Technical Equivalence: | The subject and predicate devices (cleared in K212381) have similar designs, development methods, principles of operations and performance. | |
| Mechanical Testing and
Disclosure of
Performance and Safety
Deviation: | Substantial equivalence is supported by the results of mechanical testing including insertion torque and static pullout testing, and by justification for dynamic pullout (fatigue), component interconnection, and corrosion testing according to the FDA Guidance: 'Bone Anchors - Premarket Notification (510(k)) Submissions'. Ortho-Design's suture anchors support safety and effectiveness and can be considered substantially equivalent to the predicate device (cleared in K212381). | |
| Biocompatibility: | The subject and predicate devices (cleared in K212381) are manufactured using the same approved suppliers, manufacturing facilities, manufacturing processes, chemicals, materials, and cleaning processes. All manufacturing is conducted according to the processes defined by ISO 13485 and ISO 9001. All materials, processes, and cleaning agents used for the subject device have been used in the previously cleared device(s). Therefore biocompatibility of the subject device is substantially equivalent to the predicate device.
The subject devices have been tested to be non-pyrogenic. | |
| Quality Control
Measures | For both the subject and predicate device (cleared in K212381) the methods, thresholds and criteria of the following are identical:
• Sterility
• Self-Life
• Packaging
• Pyrogenicity / Endotoxin Testing | |
| Conclusion: | The subject device demonstrates substantial equivalence by non-clinical testing consisting of mechanical, biocompatibility, sterility, shelf-life, packaging and pyrogenicity tests and adheres to the minimum requirements set out in FDA's guidance document for Bone Anchors – Premarket Notification (510(k)) Submissions. | |
| | Subject Device | Predicate Device
(Cleared in K212381) |
| Device Trade Name: | MicroTiTM Suture Anchor | MiniTiTM Suture Anchor
(Cleared in K212381) |
| Regulation Description: | Smooth or threaded metallic
bone fixation fastener. | Smooth or threaded metallic
bone fixation fastener. |
| Classification Name: | Fastener, Fixation,
Nondegradable, Soft Tissue | Fastener, Fixation,
Nondegradable, Soft Tissue |
| Regulation Number: | 21 CFR 888.3040 | 21 CFR 888.3040 |
| Device Classification: | Class II | Class II |
| Product Code: | MBI | MBI |
| Reference Device: | Depuy Mitek QuickAnchor
(K071257) | K061665; K111000; K173788;
K063453, K200523, K070758 |
| Device Description: | The MicroTiTM Suture
Anchor is a small screw-in
suture anchor used in a
variety of small-joint
applications. Despite its small
diameter, the specially
engineered thread combines
with cortical bone to provide
tremendous pull-out strength. | The MiniTiTM Suture Anchor
is a small screw-in suture
anchor used in a variety of
small-joint applications.
Despite its small diameter, the
specially engineered thread
combines with cortical bone to
provide tremendous pull-out
strength. |
| Indications for Use: | The MicroTiTM Suture
Anchor is intended to be used
for soft tissue fixation during
general orthopedic surgery.
The MicroTiTM Suture
Anchor is intended for use in
arthroscopic or open surgical
approaches for fixation of
soft tissue and ligaments to
bone/healthy tissue during
tendon and ligament repairs,
during procedures such as:
• Elbow: Ulnar/Medial
Collateral Ligament
Repair.
• Foot/Ankle: Achilles
Tendon Repair, Lateral
Stabilization, Medial
Stabilization, Achilles
Tendon Repair, Mid-foot
Reconstruction, Hallux
Valgus Reconstruction, | The MiniTiTM Suture Anchor
is intended to be used for soft
tissue fixation during general
orthopedic surgery. The
MiniTiTM Suture Anchor is
intended for use in
arthroscopic or open surgical
approaches for fixation of soft
tissue and ligaments to
bone/healthy tissue during
tendon and ligament repairs,
during procedures such as:
• Elbow: Ulnar/Medial
Collateral Ligament Repair
• Foot/Ankle: Achilles
Tendon Repair, Lateral
Stabilization, Medial
Stabilization, Achilles
Tendon Repair, Mid- foot
Reconstruction, Hallux
Valgus Reconstruction, |
| | Metatarsal Ligament Repair.
• Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction.
*The above-mentioned indications for use are identical to those of the predicate device, MiniTi™ Suture Anchor, cleared in submission K212381. | Metatarsal Ligament Repair.
• Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction. |
| Relationship to the Device: | The subject and predicate devices (cleared in K212381) have the same intended use, materials, function, packaging, and similar design features. | |
| Technological Differences: | The subject and predicate devices (cleared in K212381) have similar engineering designs and minor dimensional changes. The subject device has a reduced diameter compared to the predicate device (cleared in K212381). | |
| Clinical Characteristics: | The subject and predicate devices (cleared in K212381) are intended to be used for soft tissue fixation during general orthopedic surgery. | |
| Technical Equivalence: | The subject and predicate devices (cleared in K212381) have similar designs, development methods, principles of operations and safety performance. | |
| Mechanical Testing and Disclosure of Performance and Safety Deviation: | Substantial equivalence is supported by the results of mechanical testing including insertion torque and static pullout testing, and by justification for dynamic pullout (fatigue), component interconnection, and corrosion testing according to the FDA Guidance: 'Bone Anchors - Premarket Notification (510(k)) Submissions'. Ortho-Design's suture anchors support safety and effectiveness and can be considered substantially equivalent to the predicate device (cleared in K212381). | |
| Biocompatibility: | The subject and predicate devices (cleared in K212381) are
manufactured by the same approved suppliers, and use the
same manufacturing facilities, manufacturing processes,
chemicals, materials, and cleaning processes. All
manufacturing is conducted according to the processes
defined by ISO 13485 and ISO 9001. All materials,
processes, and cleaning agents used for the subject device
have been used in the previously cleared device(s). Therefore
biocompatibility of the subject device is substantially
equivalent to the predicate device.
The subject devices have been tested to be non-pyrogenic. | |
| Quality Control
Measures | For both the subject and predicate device (cleared in K212381)
the methods, thresholds and criteria of the following are
identical:
• Sterility
• Self-Life
• Packaging
• Pyrogenicity / Endotoxin Testing | |
| Conclusion: | The subject device demonstrates substantial equivalence by
non-clinical testing consisting of mechanical, biocompatibility,
sterility, shelf-life, packaging and pyrogenicity tests and
adheres to the minimum requirements set out in FDA's
guidance document for Bone Anchors – Premarket
Notification (510(k)) Submissions. | |
| | Subject Device | Predicate Device
(Cleared in K212381) |
| Device Trade Name: | VersaLat™ Ti Suture Anchor | VersaLat™ Suture Anchor
(Cleared in K212381) |
| Regulation Description: | Smooth or threaded metallic
bone fixation fastener. | Smooth or threaded metallic
bone fixation fastener. |
| Classification Name: | Fastener, Fixation,
Nondegradable, Soft Tissue | Fastener, Fixation,
Nondegradable, Soft Tissue |
| Regulation Number: | 21 CFR 888.3040 | 21 CFR 888.3040 |
| Device Classification: | Class II | Class II |
| Product Code: | MBI | MBI |
| Predicate Device: | VersaLat™ Suture Anchor
(K212381), manufactured by
Ortho-Design (Pty) Ltd | DePuy Mitek Healix Advance
Knotless BR Anchor
(K130917) |
| Reference Device: | K151342 - Arthrex
Swivelock Anchors | K190728; K203495; K130274
K070758 |
| Device Description: | The VersaLat™ Ti Suture
Anchor is a knotless-/suture
anchor. This titanium screw-
in anchor can be combined
with the VersaTap™ Suture
Anchor in double rotator cuff
repair surgery. Flexibility is
what differentiates this
anchor from its competitors
with surgeons being able to
fixate any number of
sutures/tapes (K150438) by
adjusting the size of the
characteristic front loop. The
extra suture provided by this
anchor can also be used for
the fixation of the biceps
tendon or any ligament
fragments. | The VersaLat™ Suture Anchor
is an innovative knotless-
/suture anchor inspired by a
top orthopedic shoulder
surgeon. This PEEK screw-in
anchor can be combined with
the VersaTap™ Suture Anchor
in double rotator cuff repair
surgery. Flexibility is what
differs this anchor from its
competitors with surgeons
being able to fixate any
number of sutures/tapes
(K150438) by adjusting the
size of the characteristic front
loop. The extra suture
provided by this anchor can
also be used for the fixation of
the biceps tendon or any
ligament fragments |
| Indications for Use: | The VersaLat™ Ti Suture
Anchor is intended to use for
fixation of soft tissue and
ligaments to bone/healthy
tissue during tendon and
ligament repairs, during
procedures such as:
• Shoulder: Rotator Cuff
Repair, Biceps Tenodesis | The VersaLat™ Suture Anchor
is intended to use for fixation
of soft tissue and ligaments to
bone/healthy tissue during
tendon and ligament repairs,
during procedures such as:
• Shoulder: Rotator Cuff
Repair, Biceps Tenodesis |
| Relationship to the Device: | Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Iliotibial Band Tenodesis Foot/Ankle: Lateral stabilization, medial stabilization, Achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, metatarsal tendon repair, bunionectomy, and digital tendon transfers. | Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Iliotibial Band Tenodesis. |
| Technological Differences: | The subject and predicate devices (cleared in K212381) have the same intended use, materials, function, packaging, and similar design features.
The subject and predicate devices (cleared in K212381) have similar engineering designs and minor dimensional changes. The subject device has a reduced diameter and an increased length compared to the predicate device (cleared in K212381). The subject devices also features a titanium threaded body whereas the predicate device features a PEEK threaded body. | |
| Clinical Characteristics: | The subject and predicate devices (cleared in K212381) are intended to be used for soft tissue fixation during general orthopedic surgery. | |
| Technical Equivalence: | Both the subject and predicate devices (cleared in K212381) have similar designs, development methods, principles of operations and safety performance. | |
| Mechanical Testing and Disclosure of Performance and Safety Deviation: | Substantial equivalence is supported by the results of mechanical testing including insertion torque and static pullout testing, and by justification for dynamic pullout (fatigue), component interconnection, and corrosion testing according to the FDA Guidance: 'Bone Anchors - Premarket Notification (510(k)) Submissions'. Ortho-Design's suture anchors support safety and effectiveness and can be considered substantially equivalent to the predicate device (cleared in K212381). | |
| Biocompatibility: | The subject and predicate devices (cleared in K212381) are
manufactured by the same approved suppliers, and use the
same manufacturing facilities, manufacturing processes,
chemicals, materials, and cleaning processes. All
manufacturing is conducted according to the processes defined
by ISO 13485 and ISO 9001. All materials, processes, and
cleaning agents used for the subject device have been used in
the previously cleared device(s). Therefore biocompatibility of
the subject device is substantially equivalent to the predicate
device.
The subject devices have been tested to be non-pyrogenic. | |
| Quality Control
Measures | For both the subject and predicate device (cleared in K212381)
the methods, thresholds and criteria of the following are
identical:
Sterility Self-Life Packaging Pyrogenicity / Endotoxin Testing | |
| Conclusion: | The subject device demonstrates substantial equivalence by
non-clinical testing consisting of mechanical, biocompatibility,
sterility, shelf-life, packaging and pyrogenicity tests and
adheres to the minimum requirements set out in FDA's
guidance document for Bone Anchors – Premarket
Notification (510(k)) Submissions. | |
| | Subject Device | Predicate Device
(Cleared in K212381) |
| Device Trade Name: | VersaLat™ Suture Anchor | VersaLat™ Suture Anchor
(Cleared in K212381) |
| Regulation Description: | Smooth or threaded metallic
bone fixation fastener. | Smooth or threaded metallic
bone fixation fastener. |
| Classification Name: | Fastener, Fixation,
Nondegradable, Soft Tissue | Fastener, Fixation,
Nondegradable, Soft Tissue |
| Regulation Number: | 21 CFR 888.3040 | 21 CFR 888.3040 |
| Device Classification: | Class II | Class II |
| Product Code: | MBI | MBI |
| Predicate Device: | VersaLat™ Suture Anchor
(K212381), manufactured by
Ortho-Design (Pty) Ltd | DePuy Mitek Healix Advance
Knotless BR Anchor
(K130917) |
| Reference Device: | K151342 - Arthrex
Swivelock Anchors | K190728; K203495; K130274
K070758 |
| Device Description: | The VersaLat™ Suture
Anchor is a knotless-/suture
anchor. This titanium screw-
in anchor can be combined
with the VersaTap™ Suture
Anchor in double rotator cuff
repair surgery. Flexibility is
what differentiates this
anchor from its competitors
with surgeons being able to
fixate any number of
sutures/tapes (K150438) by
adjusting the size of the
characteristic front loop. The
extra suture provided by this
anchor can also be used for
the fixation of the biceps
tendon or any ligament
fragments. | The VersaLat™ Suture Anchor
is an innovative knotless-
/suture anchor inspired by a
top orthopedic shoulder
surgeon. This PEEK screw-in
anchor can be combined with
the VersaTap™ Suture Anchor
in double rotator cuff repair
surgery. Flexibility is what
differs this anchor from its
competitors with surgeons
being able to fixate any
number of sutures/tapes
(K150438) by adjusting the
size of the characteristic front
loop. The extra suture
provided by this anchor can
also be used for the fixation of
the biceps tendon or any
ligament fragments |
| Indications for Use: | The VersaLat™ Suture
Anchor is intended to use for
fixation of soft tissue and
ligaments to bone/healthy
tissue during tendon and
ligament repairs, during
procedures such as:
• Shoulder: Rotator Cuff | The VersaLat™ Suture Anchor
is intended to use for fixation
of soft tissue and ligaments to
bone/healthy tissue during
tendon and ligament repairs,
during procedures such as:
• Shoulder: Rotator Cuff
Repair, Biceps Tenodesis |
| | Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Iliotibial Band Tenodesis Foot/Ankle: Lateral stabilization, medial stabilization, Achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, metatarsal tendon repair, bunionectomy, and digital tendon transfers. | Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Iliotibial Band Tenodesis. |
| Relationship to the Device: | The subject and predicate devices (cleared in K212381) have the same intended use, materials, function, packaging, and similar design features. | |
| Technological Differences: | The subject and predicate devices (cleared in K212381) have similar engineering designs and minor dimensional changes. The subject device has a reduced diameter and an increased length compared to the predicate device (cleared in K212381). | |
| Clinical Characteristics: | The subject and predicate devices (cleared in K212381) are intended to be used for soft tissue fixation during general orthopedic surgery. | |
| Technical Equivalence: | The subject and predicate devices (cleared in K212381) have similar designs, development methods, principles of operations and safety performance. | |
| Mechanical Testing and Disclosure of Performance and Safety Deviation: | Substantial equivalence is supported by the results of mechanical testing including insertion torque and static pullout testing, and by justification for dynamic pullout (fatigue), component interconnection, and corrosion testing according to the FDA Guidance: 'Bone Anchors - Premarket Notification (510(k)) Submissions'. Ortho-Design's suture anchors support safety and effectiveness and can be considered substantially equivalent to the predicate device (cleared in K212381). | |
| Biocompatibility: | The subject and predicate devices (cleared in K212381) are
manufactured by the same approved suppliers, and use the
same manufacturing facilities, manufacturing processes,
chemicals, materials, and cleaning processes. All
manufacturing is conducted according to the processes defined
by ISO 13485 and ISO 9001. All materials, processes, and
cleaning agents used for the subject device have been used in
the previously cleared device(s). Therefore biocompatibility of
the subject device is substantially equivalent to the predicate
device.
The subject devices have been tested to be non-pyrogenic. | |
| Quality Control
Measures | For both the subject and predicate device (cleared in K212381)
the methods, thresholds and criteria of the following are
identical: Sterility Self-Life Packaging Pyrogenicity / Endotoxin Testing | |
| Conclusion: | The subject device demonstrates substantial equivalence by
non-clinical testing consisting of mechanical, biocompatibility,
sterility, shelf-life, packaging and pyrogenicity tests and
adheres to the minimum requirements set out in FDA's
guidance document for Bone Anchors – Premarket
Notification (510(k)) Submissions. | |
5
6
7
8
Table 3: DEVICE B – VersaPEEK™ Suture Anchor
9
10
11
Table 4: DEVICE C – MicroTi™ Suture Anchor
12
13
14
Table 5: DEVICE D – VersaLat™ Ti Suture Anchor
15
16
17
Table 6: DEVICE E – VersaLat™ Suture Anchor
18
19