(294 days)
Not Found
No
The summary describes a physical implantable device (porous titanium wedges) and its mechanical and biocompatibility testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No.
The device is an implantable wedge used for internal bone fixation and correction of foot deformities, not a device that applies therapy.
No
Explanation: The device is an implantable wedge used for internal bone fixation and correction of foot deformities, not for diagnosing medical conditions.
No
The device description explicitly states that the device is a "porous titanium implantable wedge," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "internal bone fixation of bone fractures, fusions, or osteotomies in the foot." This describes a surgical implant used to physically support and stabilize bone, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description confirms it's a "sterile, single use porous titanium implantable wedge." This is a physical implant, not a reagent, instrument, or system used for in vitro testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is a surgical implant used for structural support during bone healing and correction of deformities.
N/A
Intended Use / Indications for Use
OsteoSinter® EVANS and COTTON wedges are intended to be used for internal bone fixation of bone fractures, fusions, or osteotomies in the foot. Specific Indications include:
- · Opening wedge osteotomies of the foot (including osteotomies for Hallux Valgus).
- · Opening wedge of Medial Cuneiform or Cotton osteotomies.
- · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy).
- · Metatarsal/Cuneiform arthrodesis.
OsteoSinter® EVANS and COTTON wedges are indicated for use with ancillary bone fixation. OsteoSinter® EVANS and COTTON wedges are not indicated for use in the spine.
Product codes
PLF
Device Description
The OsteoSinter® EVANS and COTTON wedges are sterile, single use porous titanium implantable wedges, available in varied footprints and heights, intended to be used for correction of foot deformities.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health care professionals
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 subject device was subjected to the following bench performance tests to support the assertation of substantial equivalence and evidence that no new safety or effectiveness concerns were raised:
- Static compressive strength
- Dynamic compressive strength
- Abrasion
- Friction
Biocompatibility testing, including chemical composition and animal testing, and in-vivo testing were also completed to support the equivalence of the subject device. The safety and effectiveness of OsteoSinter® EVANS and COTTON wedges is adequately supported by testing, substantial equivalence information, materials information and comparison of design characteristics provided within this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 6, 2024
Ames Medical Prosthetic Solutions, S.A.U. Emili Tarrats Plant Director Ctra. Laurea Miro 388 Sant Feliu de Llobregat, Barcelona 08980 Spain
Re: K240461
Trade/Device Name: OsteoSinter® EVANS and COTTON wedges and related accessories Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: PLF Dated: November 8, 2024 Received: November 8, 2024
Dear Emili Tarrats:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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" (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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/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,
Thomas Mcnamara -S
For: Christopher Ferreira, MS 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
3
Indications for Use
Submission Number (if known)
Device Name
OsteoSinter® EVANS and COTTON wedges and related accessories
Indications for Use (Describe)
OsteoSinter® EVANS and COTTON wedges are intended to be used for internal bone fixation of bone fractures, fusions, or osteotomies in the foot. Specific Indications include:
- · Opening wedge osteotomies of the foot (including osteotomies for Hallux Valgus).
- · Opening wedge of Medial Cuneiform or Cotton osteotomies.
- · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy).
- · Metatarsal/Cuneiform arthrodesis.
OsteoSinter® EVANS and COTTON wedges are indicated for use with ancillary bone fixation. OsteoSinter® EVANS and COTTON wedges are not indicated for use in the spine
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
K240461 Page 1 of 9
Image /page/4/Picture/1 description: The image shows the logo for AMES MEDICAL. The logo consists of a stylized letter "M" formed by three teal-colored, rounded triangles. Below the symbol, the words "AMES MEDICAL" are written in a simple, sans-serif font, with "AMES" in a slightly larger font size than "MEDICAL".
OsteoSinter® EVANS and COTTON wedges and related accessories 510(k) Premarket Notification Submission
510(k) SUMMARY
DATE OF SUBMISSION: SUBMITTER NAME: SUBMITTER ADDRESS: 2024-12-06 AMES MEDICAL Prosthetic Solutions S.A.U. Camí de Can Ubach 8, Pol. Ind. "Les Fallulles" 08620 Sant Vicenç dels Horts, Barcelona SPAIN
CONTACT: TELEPHONE: e-mail:
Emili Tarrats +34 667 172 593 emili.tarrats@ames.group
DEVICE TRADE NAME: OsteoSinter® EVANS and COTTON wedges and related accessories Bone Wedge COMMON NAME: REGULATION DESCRIPTION: Single/Multiple component metallic bone fixation appliances and accessories Class II (Special Controls) CLASS: REGULATION NUMBER: 21 CFR 888.3030 PRODUCT CODE: PLF REFERENCE PRODUCT CODE:HRS
PREDICATE DEVICE
| K142724 | BIOFOAM® Bone Wedge |
|---|---|
| K151256 | Arthrex BioSync® Bone Wedge |
DEVICE DESCRIPTION:
The OsteoSinter® EVANS and COTTON wedges are sterile, single use porous titanium implantable wedges, available in varied footprints and heights, intended to be used for correction of foot deformities.
5
K240461 Page 2 of 9
Image /page/5/Picture/1 description: The image contains the logo for AMES MEDICAL. The logo consists of a stylized letter "M" formed by three teal-colored, angled shapes. Below the symbol, the text "AMESMEDICAL" is written in a dark gray sans-serif font. The word "AMES" is slightly larger and bolder than "MEDICAL".
OsteoSinter® EVANS and COTTON wedges and related accessories 510(k) Premarket Notification Submission
510(k) SUMMARY
INTENDED USE / INDICATIONS FOR USE:
As established in the Indications for Use Statement:
OsteoSinter® EVANS and COTTON wedges are intended to be used for internal bone fixation of bone fractures, fusions, or osteotomies in the foot. Specific Indications include:
- Opening wedge osteotomies of the bones of the foot (including osteotomies for Hallux . Valgus).
- Opening wedge of Medial Cuneiform or Cotton osteotomies. ●
- Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z ● Osteotomy).
- Metatarsal/Cuneiform arthrodesis.
OsteoSinter® EVANS and COTTON wedges are indicated for use with ancillary bone fixation. OsteoSinter® EVANS and COTTON wedges are not indicated for use in the spine.
SUMMARY DISCUSSION OF NON-CLINICAL DATA:
The OsteoSinter® EVANS and COTTON wedges are substantially equivalent to the predicates devices (BIOFOAM® Bone Wedge, K142724 and Arthrex BioSync® Bone Wedge, K151256) in intended use/indications and in important physical and performance specifications. The subject and predicate device are substantially equivalent in design, features and material. The subject device was subjected to the following bench performance tests to support the assertation of substantial equivalence and evidence that no new safety or effectiveness concerns were raised:
- Static compressive strength
- Dynamic compressive strength ●
- Abrasion ●
- Friction
Biocompatibility testing, including chemical composition and animal testing, and in-vivo testing were also completed to support the equivalence of the subject device. The safety and effectiveness of OsteoSinter® EVANS and COTTON wedges is adequately supported by testing, substantial equivalence information, materials information and comparison of design characteristics provided within this premarket notification.
SUMMARY DISCUSSION OF CLINICAL DATA:
Non-clinical test data are submitted to support this premarket notification and to establish substantial
6
K240461 Page 3 of 9
Image /page/6/Picture/1 description: The image shows the logo for AMES MEDICAL. The logo consists of a stylized letter "M" in teal, with the word "AMESMEDICAL" in black, sans-serif font below it. The "M" is made up of three separate, curved shapes that come together to form the letter.
OsteoSinter® EVANS and COTTON wedges and related accessories 510(k) Premarket Notification Submission
510(k) SUMMARY
equivalence. No clinical studies are submitted.
SUMMARY OF SUBSTANTIAL EQUIVALENCE DISCUSSION:
A comparison of the technological characteristic of the subject device with those of the predicate device is provided in the following table.
7
Image /page/7/Picture/1 description: The image shows the logo for AMESMEDICAL. The logo consists of a stylized letter "M" in teal, with the word "AMESMEDICAL" printed in black below it. The "M" is made up of three separate shapes that come together to form the letter.
OsteoSinter® EVANS and COTTON wedges and related accessories 510(k) Premarket Notification Submission
| Equivalent /
similar device | Subject Device | Predicate Devices | | Equivalence
Discussion
vs predicate device |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| | AMES Medical OsteoSinter®
EVANS and COTTON wedges | WRIGHT BIOFOAM® Bone wedge | Arthrex BioSync® Bone
Wedge | - |
| 510(k) | | K142724 | K151256 | - |
| Product Code | HRS | HRS; HWC | PLF, HRS, HWC | - |
| Class | Class II | Class II | Class II | Equivalent |
| Intended users | Health care professionals | Health care professionals | Health care
professionals | Same |
| Contraindications | · Infection.
·Physiologically or psychologically inadequate
patient (conditions that tend to limit the patient's
ability or willingness to restrict activities or follow
post-operative care
instructions).
· Inadequate skin, bone or neurovascular
conditions, which may delay healing.
· Growing patients with open epiphyses.
· Foreign body sensitivity. Where material
sensitivity is suspected, testing is to be completed
prior to device implantation. | · Infection
· Physiologically or psychologically
inadequate patient
· Inadequate skin, bone, or
neurovascular status
• Irreparable tendon system
· Possibility for conservative
treatment
• Growing patients with open
epiphyses
· Patients with high levels of activity | 1. Insufficient quantity or
quality of bone.
2. Blood supply
limitations and previous
infections.
which may retard
healing.
3. Foreign body
sensitivity. Where
material sensitivity
is suspected,
appropriate tests should | Equivalent |
8
K240461 Page 5 of 9
Image /page/8/Picture/1 description: The image shows the logo for AMES MEDICAL. The logo consists of a stylized letter "M" in teal, with the words "AMES MEDICAL" in black below it. The logo is simple and modern, and the teal and black color scheme is professional and clean.
OsteoSinter® EVANS and COTTON wedges and related accessories 510(k) Premarket Notification Submission
| • Patient smoking may result in delayed healing,
non-healing and/or compromised stability in or
around the placement site. | be made and
sensitivity ruled out prior
to implantation.
4. Any active infection
or blood supply
limitations.
5. Conditions that tend
to limit the patient's
ability or
willingness to restrict
activities or follow
directions
during the healing
period.
6. The use of this device
may not be suitable for
patients with insufficient
or immature bone. The
physician should
carefully assess bone
quality
before performing
orthopedic surgery on
patients
who are skeletally
immature. The use of
this
medical device and the
placement of hardware |
| ---------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
9
Image /page/9/Picture/1 description: The image shows the logo for AMESMEDICAL. The logo consists of a stylized letter "M" in teal above the word "AMESMEDICAL" in black. The "M" is formed by two angled lines that meet at the top, creating a peak.
OsteoSinter® EVANS and COTTON wedges and related accessories 510(k) Premarket Notification Submission
| | | | or implants must not
bridge, disturb or disrupt
the growth plate.
7. Do not use for
surgeries other than
those indi-cated. | |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| MRI Environments | Concerning Magnetic Resonance Environments;
the devices have not been assessed for safety and
compatibility in the Magnetic Resonance (MR)
environment. The devices have not been tested for
heating or migration in the MR environment. | Concerning Magnetic Resonance
Environments The devices described
in this package insert have not been
evaluated for safety and compatibility
in the MR environment. The devices
described in this package insert have
not been tested for heating or
migration in the MR environment. | This device has not
been evaluated for
safety and compatibility
in the magnetic
resonance (MR)
environment. This
device has not
been tested for heating,
migration or image
artifact in the MR
environment. The safety
of the device in the MR
environment is
unknown. Scanning a
patient who has this
device may result in
patient injury. If the
implant is manufactured
from a metallic material,
surgeons can expect
that MR artifacts will be
present during routine
MR imaging. | Equivalent |
10
Image /page/10/Picture/1 description: The image shows the logo for AMESMEDICAL. The logo consists of a stylized letter "A" in teal, with the word "AMESMEDICAL" written in black sans-serif font below it. The logo is simple and modern, and the teal color is eye-catching.
OsteoSinter® EVANS and COTTON wedges and related accessories 510(k) Premarket Notification Submission
| Storage conditions | All implants and related accessories must be
stored in a clean, dry environment and be
protected from sunlight and extremes in
temperature and should not be used after the
expiry date. | All implants must be stored in a
clean, dry environment and be
protected from sunlight and extremes
in temperature. | This device must be
stored in the original
unopened packaging,
away from moisture and
should not be used after
the expiration date. | Equivalent |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | PHYSICAL AND MECHANICAL PROPERTIES | | | |
| Material | CP Titanium | CP Titanium | CP Titanium | Same |
| Total Porosity (%) | 62-66 | 60-70 | Average 58% | Same |
| Pore cell size
averages (μm)
by SEM | 532,20±225 | 530
512,53±96,03 | 434-660 | Equivalent |
| Average
Interconnected
pores diameter
(μm) | 270,36±96,29 | 200
192,45±45,73 | 229 | Equivalent |
| Powder particle
size (μm) | 106-250 | Not defined | Not defined | Similar |
| Apparent Elastic
Modulus (GPa) | 2,8 | 2,7 | 3,2 | Equivalent |
| Compressive yield | 31 | 86 | Not defined | Similar |
11
K240461
Page 8 of 9
Image /page/11/Picture/1 description: The image shows the logo for AMESMEDICAL. The logo consists of a stylized letter "M" in teal, with the word "AMESMEDICAL" in black text below it. The "M" is formed by three separate shapes that come together to create the letter.
OsteoSinter® EVANS and COTTON wedges and related accessories 510(k) Premarket Notification Submission
| Strength (MPa) | ||||
|---|---|---|---|---|
| Abrasion (% of | ||||
| weight loss at 1000 | ||||
| N) | 0,32 | 13 | 0.2 | Equivalent to |
| K151256 | ||||
| Friction coefficient | $1,22 \pm 0,28$ | $0,58 \pm 0,02$ | $1,07 \pm 0,10$ | Equivalent to |
| K151256 | ||||
| Compressive | ||||
| fatigue limit | 5M cycles exceed 11.3 MPa, without failure | Not defined | 10M cycles | |
| exceed | ||||
| 10MPa, | ||||
| without failure | Equivalent to | |||
| K151256 | ||||
| Technology | Powder metal | |||
| sintering | Titanium deposition on open-cell | |||
| scaffold | Diffusion bonding | Similar to K142724 |
12
K240461 Page 9 of 9
Image /page/12/Picture/1 description: The image shows the logo for AMES MEDICAL. The logo consists of a stylized letter "A" formed by three teal-colored, leaf-like shapes. Below the symbol, the words "AMES MEDICAL" are written in a simple, sans-serif font, with "AMES" in a larger font size than "MEDICAL".
OsteoSinter® EVANS and COTTON wedges and related accessories 510(k) Premarket Notification Submission
510(k) SUMMARY
The subject and predicate device are substantially equivalent in design, features and material. Based on the non-clinical data provided in this submission, the technological characteristics of OsteoSinter® EVANS and COTTON wedges raise no new issues related to safety and effectiveness. Based on the information provided in this submission, OsteoSinter® EVANS and COTTON wedges are substantially equivalent to the predicates devices (K142724 and K151256).
CONCLUSIONS:
The design characteristics, material and intended use of the OsteoSinter® EVANS and COTTON wedges are substantially equivalent to the predicates devices BIOFOAM® Bone Wedge (K142724) and Arthrex BioSync® Bone Wedge (K151256). The safety and effectiveness of the OsteoSinter® EVANS and COTTON wedges are adequately supported by the substantial equivalence information, materials information and performance data provided within this Premarket Notifcation submission.