(172 days)
K1603044
No
The summary describes a traditional orthopedic plating and screw system for fracture fixation. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an implantable system for internal fixation of bone fractures, which aids in healing by stabilizing the bones, rather than providing direct therapeutic treatment.
No.
The Apollo Ankle Fracture Plating System is used for the fixation of fractures, osteotomies, and non-unions, functioning as an implantable medical device for treatment rather than diagnosis.
No
The device description explicitly states that the system consists of "implantable components" including "plates and locking and non-locking screws" made of Titanium alloy and PEEK. This indicates the device is a physical implant system, not software only.
Based on the provided information, the Apollo™ Ankle Fracture Plating System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for the fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device consists of implantable components (plates, screws, washers) made of titanium alloy and PEEK, along with instrumentation for delivery. This is consistent with a surgical implant system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
Therefore, the Apollo™ Ankle Fracture Plating System is a surgical implant system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Apollo™ Ankle Fracture Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:
- · Lateral Malleolar Fractures
- Syndesmosis Injuries
- · Medial Malleolar Fractures
- Bi-Malleolar Fractures
- Tri-Malleolar Fractures
- Posterior Malleolar Fractures
- Distal Anterior Tibia Fractures
- · Vertical Shear Fractures of the Medial Malleolus
- Pilon Fractures
- Distal Tibia Shaft Fractures
- Distal Fibula Shaft Fractures
- Distal Tibia Periarticular Fractures
- Medial Malleolar Avulsion Fractures
- · Lateral Malleolar Avulsion Fractures
Apollo Locking Screws are intended for use with Apollo's Plating Systems.
Apollo non-Locking Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Apollo washer is intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/ load over a large area when used for fracture fixation of bone fragments.
Apollo 1/3 tubular plates are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repar, and fracture fixation, appropriate for the size of the device.
Product codes
HRS, HWC
Device Description
ApolloTM Ankle Fracture Plating System consists of implantable components that will be include an array of Titanium alloy Ti-6AL-4V ELI (ASTM F3001) / PEEK plates and locking and non-locking screws.
The screws are offered in configurations that include a range of Titanium alloy Ti-6AL-4V ELI (ASTM F136) screws. A variety of instrumentation is offered as part of the kit to facilitate delivery of the implants. The implantable devices are provided sterile via Gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal tibia and fibula
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)
The plate components were tested via ASTM F382 and were shown to be at least equivalent to the predicate devices.
Torsional strength, driving torque and axial pullout testing (per ASTM F543 and FDA Guidance for Bone Screws and Washers, December 2020) confirmed that the Subject device screws performed as intended and are at least equivalent to the predicate devices. Static 3-point bending, and dynamic 3-point bending per ASTM F1264 further confirmed the performance and substantial equivalence of the Subject device screws.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K1603044
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
March 11, 2022
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side.
GLW Medical Inc % Cheryl Wagoner Consultant Wagoner Consulting LLC 5215 Crosswinds Drive Wilmington, North Carolina 28409
Re: K213005
Trade/Device Name: Apollo Ankle Fracture Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: February 8, 2022 Received: February 9, 2022
Dear Cheryl Wagoner:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 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,
For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K213005
Device Name Apollo Ankle Fracture Plating System
Indications for Use (Describe)
Apollo™ Ankle Fracture Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:
- · Lateral Malleolar Fractures
- Syndesmosis Injuries
- · Medial Malleolar Fractures
- Bi-Malleolar Fractures
- Tri-Malleolar Fractures
- Posterior Malleolar Fractures
- Distal Anterior Tibia Fractures
- · Vertical Shear Fractures of the Medial Malleolus
- Pilon Fractures
- Distal Tibia Shaft Fractures
- Distal Fibula Shaft Fractures
- Distal Tibia Periarticular Fractures
- Medial Malleolar Avulsion Fractures
- · Lateral Malleolar Avulsion Fractures
Apollo Locking Screws are intended for use with Apollo's Plating Systems.
Apollo non-Locking Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Apollo washer is intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/ load over a large area when used for fracture fixation of bone fragments.
Apollo 1/3 tubular plates are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repar, and fracture fixation, appropriate for the size of the device.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
Traditional 510(k) Premarket Notification Apollo™ Ankle Fracture Plating System
510(k) Summary (as required by 21 CFR 807.92)
| Date Prepared | September 17, 2021 |
|---|---|
| Manufacturer | GLW, Inc. |
| Address | 300 Sylvan Ave |
| Englewood Cliff, NJ 07632 | |
| Telephone | 917-794-2583 |
| Contact Person | Arundhati Radhakrishnan |
| Address | 300 Sylvan Ave |
| Englewood Cliff, NJ 07632 | |
| Telephone | 201-268-3281 |
| Arundhati.radhakrishnan@glwmed.com |
| Trade Name | Apollo™ Ankle Fracture Plating System |
|---|---|
| Common Name | Plate, Fixation, Bone |
| Screw, Fixation, Bone | |
| Panel Code | Orthopaedics/87 |
| Classification Name | Single/multiple component metallic bone fixation appliances |
| and accessories. | |
| Smooth Or Threaded Metallic Bone Fixation Fastener | |
| Class | Class II |
| Regulation Number | 21 CFR 888.3030 |
| 21CFR 888.3040 | |
| Product Code | HRS |
| HWC |
| Name of Primary Predicate
| Device | 510(k) # | Manufacturer |
|---|---|---|
| Name of Reference | ||
| Device(s) | 510(k) # | Manufacturer |
| CREED™ Cannulated | ||
| Screws | K200291 | GLW, Inc |
| Description | ApolloTM Ankle Fracture Plating System consists of
implantable components that will be include an array of
Titanium alloy Ti-6AL-4V ELI (ASTM F3001) / PEEK plates
and locking and non-locking screws.
The screws are offered in configurations that include a
range of Titanium alloy Ti-6AL-4V ELI (ASTM F136) screws.
A variety of instrumentation is offered as part of the kit to |
| ------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
5
Traditional 510(k) Premarket Notification
Apollo™ Ankle Fracture Plating System
| | facilitate delivery of the implants. The implantable devices
are provided sterile via Gamma irradiation. |
| -- | ------------------------------------------------------------------------------------------------------------- |
|---|
| Indications and
Intended Use | Apollo™ Ankle Fracture Plating System is intended for
fixation of fractures, osteotomies, and non-unions of the
distal tibia and fibula such as:
Lateral Malleolar Fractures Syndesmosis Injuries Medial Malleolar Fractures Bi-Malleolar Fractures Tri-Malleolar Fractures Posterior Malleolar Fractures Distal Anterior Tibia Fractures Vertical Shear Fractures of the Medial Malleolus Pilon Fractures Distal Tibia Shaft Fractures Distal Fibula Shaft Fractures Distal Tibia Periarticular Fractures Medial Malleolar Avulsion Fractures Lateral Malleolar Avulsion Fractures Apollo Locking Screws are intended for use with Apollo's
Plating Systems.
Apollo non-Locking Screws are indicated for use in bone
reconstruction, osteotomy, arthrodesis, joint fusion, fracture
repair, and fracture fixation, appropriate for the size of the
device.
Apollo washer is intended to prevent a screw head from
breaking through the cortex of the bone by distributing the
forces/load over a large area when used for fracture fixation
of bone fragments.
Apollo 1/3 tubular plates are indicated for use in bone
reconstruction, osteotomy, arthrodesis, joint fusion, fracture
repair, and fracture fixation, appropriate for the size of the
device. |
|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics
and Substantial
Equivalence | Documentation was provided to demonstrate that the
Subject device is substantially equivalent to the primary
predicate Wright Medical Ortholoc 3Di Ankle Fracture
System (K1603044). The Subject device is substantially
equivalent to the predicate devices in intended use,
indications for use, materials, technological characteristics,
and labeling. |
6
г
| Performance
Data | The plate components were tested via ASTM F382 and were
shown to be at least equivalent to the predicate devices. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Torsional strength, driving torque and axial pullout testing (per
ASTM F543 and FDA Guidance for Bone Screws and
Washers, December 2020) confirmed that the Subject device
screws performed as intended and are at least equivalent to
the predicate devices. Static 3-point bending, and dynamic 3-
point bending per ASTM F1264 further confirmed the
performance and substantial equivalence of the Subject
device screws. |
| Conclusion | Based on the intended use, indications for use, technological
characteristics, materials, and comparison to predicate
reference devices, the Subject device has been shown to be
substantially equivalent to legally marketed predicate
devices. |
| ------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|