← Product Code [PBF](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PBF) · K211614
# CenterMed Patient Matched Assisted Surgical Planning (ASP) System (K211614)
_Centermed, Inc. · PBF · Aug 4, 2022 · Orthopedic · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PBF/K211614
## Device Facts
- **Applicant:** Centermed, Inc.
- **Product Code:** [PBF](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PBF.md)
- **Decision Date:** Aug 4, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3030
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
## Intended Use
CenterMed Patient Matched Assisted Surgical Planning (ASP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the ASP system and the result is an output data file. This file may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models of the Fibula and Ilium, surgical guides for harvesting bone grafts from the Fibula or Ilium, and surgical planning case reports for use in Maxillofacial reconstructive surgeries. CenterMed Patient Matched ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
## Device Story
System processes patient CT/DICOM imaging data to create patient-specific anatomical models and surgical guides for Maxillofacial reconstructive surgeries. Workflow: surgeon provides imaging data; trained engineers use COTS software (e.g., Materialise Mimics) for segmentation and virtual surgical planning; surgeon reviews and approves digital models/plans; system generates 3D STL files; additive manufacturing (Selective Laser Sintering) produces physical models/guides from PA-12 polyamide; stainless steel sleeves added to guides. Output includes anatomical models, surgical guides, and planning reports. Used in clinical settings; operated by engineers and physicians. Guides/models provided non-sterile; end-user performs steam sterilization. Output assists surgeons in osteotomy positioning and graft harvesting, potentially improving surgical precision and planning efficiency.
## Clinical Evidence
No clinical or animal studies were performed. Substantial equivalence is supported by non-clinical bench testing, including mechanical testing (ISO 178, ISO 20753, ASTM D638, ISO 527-2), dimensional tolerance testing, wear debris testing, biocompatibility (ISO 10993-5, -10, -11), sterilization validation (ANSI/AAMI/ISO 17665-1), and software validation of COTS applications.
## Technological Characteristics
System uses COTS software for image segmentation and 3D modeling. Physical outputs manufactured via Selective Laser Sintering (SLS) using medical-grade Polyamide (PA-12). Surgical guides incorporate 316L stainless steel sleeves. Passive device; non-sterile; steam-sterilizable (10-6 SAL). Connectivity involves digital transfer of DICOM files. Software is used for planning and design; manufacturing is additive.
## Regulatory 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.
## Predicate Devices
- KLS Martin Individual Patient Solutions (IPS) Planning System ([K192979](/device/K192979.md))
## Submission Summary (Full Text)
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August 4, 2022
Image /page/0/Picture/1 description: The image shows 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.
CenterMed, Inc. Jash Bhayani Chief Operating Officer 226 N Wiget Ln Walnut Creek, California 94598
Re: K211614
Trade/Device Name: CenterMed Patient Matched Assisted Surgical Planning (ASP) System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: PBF, LLZ Dated: July 29, 2022 Received: August 1, 2022
Dear Mr. Bhayani:
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
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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,
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
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# Indications for Use
510(k) Number (if known) K211614
Device Name CenterMed Patient Matched Assisted Surgical Planning (ASP) System
Indications for Use (Describe)
CenterMed Patient Matched Assisted Surgical Planning (ASP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the ASP system and the result is an output data file. This file may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models of the Fibula and Ilium, surgical guides for harvesting bone grafts from the Fibula or Ilium, and surgical planning case reports for use in Maxillofacial reconstructive surgeries. CenterMed Patient Matched ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
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)
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510(k) Summary
K211614 Page 1 of 13
centermed
## 510(k) Summary
| Submitter Information | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | CenterMed, Inc. |
| Submitter Address: | 226 N Wiget Ln, |
| | Walnut Creek, CA 94598 |
| Contact Person: | Jash Bhayani |
| Contact Title: | Chief Operating Officer |
| Phone number: | 855-840-8823 |
| E-mail address: | Jash.bhayani@CenterMed.com |
| Date Prepared: | July 29, 2022 |
| | The content is prepared based on the requirements of 21
CFR 807.92 |
| Submission Information | |
| Trade Name: | CenterMed Patient Matched Assisted Surgical Planning
(ASP) System |
| Common Name: | System for the creation of patient specific anatomical
models, surgical guides and surgical planning case reports |
| Classification Name: | Orthopedic Surgical Planning and Instrument Guides (21
CFR 888.3030) (Primary)
System, Image Processing, Radiological (21 CFR 892.2050) |
| Regulatory Class: | Class II |
| Product Code: | PBF, LLZ |
| Predicate Device: | KLS Martin Individual Patient Solutions (IPS) Planning
System (K192979) |
| Device Description: | CenterMed Patient Matched Assisted Surgical Planning
(ASP) System is a combination of software design and
additive manufacturing for customized virtual pre-surgical
treatment planning in Maxillofacial reconstructive surgeries.
The system processes patients' imaging data files obtained
from the surgeons for treatment planning and outputs various
patient-specific products (both physical and digital),
including surgical guides for harvesting bone grafts from the
Fibula or Ilium, anatomical models of the Fibula and Ilium,
and surgical planning case reports for use in Maxillofacial
reconstructive surgeries. The physical products (surgical
guides, anatomical models) are manufactured with
biocompatible polyamide (PA-12) using additive
manufacturing (Selective Laser Sintering). |
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# centermed
Indications for Use: CenterMed Patient Matched Assisted Surgical Planning (ASP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the ASP system and the result is an output data file. This file may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models of the Fibula and Ilium, surgical guides for harvesting bone grafts from the Fibula or Ilium, and surgical planning case reports for use in Maxillofacial reconstructive surgeries. CenterMed Patient Matched ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
#### 1 Abbreviations
| Abbreviation | Definition |
|--------------|-------------------------------------------------------------|
| ASP | Assisted Surgical Planning |
| COTS | Commercially off-the-shelf |
| CT | Computer Tomography |
| DICOM | File Format; Digital Imaging and Communications in Medicine |
| IPS | Individual Patient Solutions |
| PA-12 | Polyamide 12 |
| SAL | Sterility Assurance Level |
| SLA | Stereolithography |
| SLS | Selective Laser Sintering |
| STL | File format used in 3D printing |
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#### 510(k) Summary
#### 2 General Workflow
The general workflow of CenterMed Patient Matched Assisted Surgical Planning System begins with software simulation of patients' imaging data files obtained from the surgeon for treatment planning. Products (surgical guides and anatomical models) are designed and approved by the surgeon based on these imaging data files and converted to 3D STL files. Simultaneously, a surgical planning case report is created based on the same imaging data files as well as the STLs of the designed products. Receiving signed approval from the surgeon, the STL files of the product are sent to manufacturing to be pre-processed, 3D-printed, and post-processed. The completed output of the system includes the surgical planning case report, anatomical models, and corresponding surgical guides. These are packaged, labeled, and sent to the surgeon clean and non-sterile. The surgeon or relevant hospital staff will sterilize the surgical guides and anatomical models before use in the operating room. The workflow is shown in Figure 1.
Image /page/5/Figure/3 description: This image is a flowchart that outlines the process of creating anatomical models and surgical guides from CT/DICOM images. The process begins with inputting CT/DICOM images, followed by surgical treatment planning using software like MIMICS and 3-Matic. The next steps include data preparation using software like Magics and PSW, material preparation involving polyamide powder mixing, 3D printing using SLS printing technique, post-processing steps like cooling down, unpacking, sieving, sandblasting, packaging, and labeling, and finally, the output of anatomical models, surgical guides, and surgical planning case reports, which are then sterilized by the end user.
Figure 1: General Workflow of CenterMed Patient Matched ASP System
Image /page/5/Picture/6 description: The image contains the word "Centermed" in a bold, sans-serif font. The word is colored in a dark red or maroon hue. A horizontal line is placed above the text, spanning the entire length of the word, and is also in the same dark red color.
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#### 3 Technological Characteristics / Substantial Equivalence Discussion
Both the subject device and predicate device have similar indications for use.
#### Indications for use of the subject device
CenterMed Patient Matched Assisted Surgical Planning (ASP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the ASP system and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs, including anatomical models of the Fibula and Ilium, surgical guides for harvesting bone grafts from the Fibula or Ilium, and surgical planning case reports for use in Maxillofacial reconstructive surgeries. The subject device and predicate device are also both intended as a pre-operative software tool for simulating/ evaluating surgical treatment options.
#### Indications for use of the predicate device:
The KLS Marin Individual Patient Solutions (IPS) Planning System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the IPS Planning System and the result is an output data file that mav then be provided as digital models or used in an additive manufacturing portion of the system that produces physical outputs including anatomical models, guides and case reports for use in thoracic (excluding spine) and reconstructive surgeries. The IPS Planning System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.
#### 4 Similarities to Predicate
Both the subject device and predicate device fit the same premarket regulation and are identical in conditions of use.
Both the subject device and predicate device share the same fundamental technologies. They both use a combination of software and hardware. Commercially off-the-shelf (COTS) software systems are used for image transfer, manipulation, surgical simulation as well as digital model creation of patient specific anatomical models, and surgical guides. These software systems are intended to be operated by well-trained engineers and the outputs are evaluated by physicians. The additive manufacturing hardware is used to manufacture the physical models from the digital models.
Both the subject device and predicate device share the same fundamental technologies as follows:
- Both use medical imaging data, such as CT scans, in DICOM format as input data file;
- Both have the same system outputs, including anatomical models, and surgical guides; ●
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-
- Both generate digital models and surgical planning case reports to assist physicians in . how to use the products during clinical operation;
- . Both use the same materials for surgical guides (Polyamide-12);
- Both use additive manufacturing techniques for product manufacturing;
- Both use the same manufacturing methods for printing surgical guides (Selective Laser ● Sintering (SLS));
- Both are passive medical devices; ●
- Both are patient-specific devices;
- Both are provided for single-use;
- Both are provided non-sterile with an end-user sterilization method of steam sterilization . with the validated assurance level of 10-6 SAL;
- Both use temporary screws for surgical guide fixation to temporarily fix the surgical . guide to the target bone surface for more precise guidance of the osteotomy position;
- . Both devices require trained employees/engineers who utilize the software applications to manage data and work with the physician to create the virtual surgical plan;
- . Both devices need the physician to provide input for surgical planning and give feedback of the system outputs by viewing digital models modified by trained employees/engineers during the planning session.
## 5 Differences from Predicate
- The predicate device indicates the thoracic region in their indications for use which is . not present in the subject device. The subject device is indicated for the fibula and ilium regions of the body.
- Subject device creates anatomical models using Polyamide-12 (PA-12) material with a . SLS manufacturing process, whereas the predicate device uses resin material with an SLA manufacturing process.
- For the predicate device, manufacturing materials include epoxy/resin and acrylic for . anatomical models, and polyamide, Titanium Alloy (Ti-6A1-4V) and CP Titanium for guides. The subject device only uses PA-12 to manufacture all anatomical models, and surgical guides.
- . The predicate device provides two kinds of surgical guides, one made with polyamide and the other made with Titanium Alloy (Ti-6Al-4V) and CP Titanium. The subject device only uses surgical guides made of polyamide, along with medical grade 316L stainless steel sleeves.
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# centermed
- The predicate device uses previously cleared fixation screws which range from 2.3mm -. 3.2mm diameter, with length of 7mm - 17mm. The subject device recommends a range of standard screw sizes to the doctor (diameter 1.5mm - 2.1mm, length 5mm - 22mm) (Standard screw sizes determined by manufacturer catalogs of medical grade screws for maxillofacial surgeries).
- Both the predicate and subject device utilize Materialise Mimics for image segmentation . and processing, but the predicate and subject device use different additional commercially off-the-shelf (COTS) software applications for image segmentation and processing. Additionally, the subject device utilizes two (2) commercially off-the-shelf (COTS) software for manufacturing.
- The predicate device has one contraindication that is not present in the subject device, . "Bone tumors located in the implant base region". The subject device does not include implants and therefore this contraindication is not relevant to the subject device. All other contraindications are identical to the predicate device.
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Image /page/9/Picture/1 description: The image features the word "entermed" in a stylized, red font. The word is presented in a bold, italicized typeface, giving it a dynamic and modern appearance. A registered trademark symbol is located to the right of the word.
K211614 Page 7 of 13
# Table 1: Subject and Predicate Device Comparison
| | Subject Device | Predicate Device |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | CenterMed Patient Matched Assisted Surgical
Planning (ASP) System | KLS Martin IPS Planning System (K192979) |
| Product Code | LLZ, PBF | LLZ, PBF |
| Classification | 21 CFR 892.2050, Class II
21 CFR 888.3030, Class II | 21 CFR 892.2050, Class II
21 CFR 888.3030, Class II |
| Common Name | System for the creation of patient specific anatomical
models, surgical guides and surgical planning case
reports | System for the creation of patient specific anatomical
models, cutting/marking guides, and case reports |
| Indications for use | CenterMed Patient Matched Assisted Surgical Planning
(ASP) System is intended for use as a software system
and image segmentation system for the transfer of
imaging information from a medical scanner such as a
CT based system. The input data file is processed by
the ASP system and the result is an output data file.
This file may then be provided as digital models or
used as input to a rapid prototyping portion of the
system that produces physical outputs including
anatomical models of the Fibula and Ilium, surgical
guides for harvesting bone grafts from the Fibula or
Ilium, and surgical planning case reports for use in
Maxillofacial reconstructive surgeries. CenterMed
Patient Matched ASP System is also intended as a pre-
operative software tool for simulating/evaluating
surgical treatment options. | The KLS Martin Individual Patient Solutions (IPS)
Planning System is intended for use as a software system
and image segmentation system for the transfer of
imaging information from a medical scanner such as a CT
based system. The input data file is processed by the IPS
Planning System and the result is an output data file that
may then be provided as digital models or used in an
additive manufacturing portion of the system that
produces physical outputs including anatomical models,
guides, and case reports for use in thoracic (excluding
spine) and reconstructive surgeries. The IPS Planning
System is also intended as a pre-operative software tool
for simulating / evaluating surgical treatment options. |
| Contraindications | 1. Active infections (obvious, or clinically apparent).
2. Hypersensitivity to foreign bodies.
3. Circulatory problems, systematic diseases, or
metabolic disorders.
4. Insufficient or inadequate bone tissue.
5. Secondary diseases such as degenerative processes
that may have negative influences.
6. Interventions carried out in a non-sterile
environment
7. Regions exposed to inappropriate forces or excessive
weight loads
8. Patients unwilling to follow instructions during the
postoperative phase due to their mental,
neurological, or physical condition.
9. Obvious drug or alcohol abuse
10. Significant changes to the patient's anatomy have
occurred since the medical scan used for planning
purposes was obtained. | 1. Obvious infections.
2. Hypersensitivity to foreign bodies.
3. Circulatory problems, systemic diseases, and metabolic
disorders.
4. Insufficient or inadequate bone tissue.
5. Secondary diseases such as degenerative processes that
may negatively influence the healing process.
6. Interventions carried out in a non-sterile environment.
7. Regions exposed to inappropriate forces or excessive
weight loads.
8. Patients unwilling or unable to follow instructions
during the postoperative phase due to their mental,
neurological, or physical condition.
9. Bone tumors located in the implant base region.
10. Obvious drug or alcohol abuse.
11. Significant changes to the patient's anatomy has
occurred since the medical scan used for planning
purposes was obtained. |
| Clinical
Application | Maxillofacial reconstructive surgeries | Thoracic (excluding spine) and reconstructive surgeries |
| Prescription Use | Yes, intended to be used by physicians, not for use by
patients. | Yes, intended to be used by physicians, not for use by
patients. |
| Energy
used/delivered | Passive | Passive |
| System Inputs | CT, DICOM images,
Anatomical models, | CT, DICOM images
Anatomical models, |
| System Outputs | Surgical guides, Surgical planning case reports | Guides, Case reports |
| Materials | Anatomical models: Medical Grade Polyamide (PA-12) | Anatomical models: Epoxy/Resin, Acrylic |
| 510(k) Summary | | |
| | Surgical guides:
3D printed part: Medical Grade polyamide (PA-12)
Sleeve: Medical Grade Stainless Steel 316L | Cutting/Marking guides: Polyamide, Titanium Alloy (Ti-
6Al-4V), CP Titanium |
| Manufacturing
Method | Medical Grade Polyamide (PA-12):
3D (Additive; Selective Laser Sintering (SLS))
Medical Grade Stainless Steel 316L:
Traditional (Subtractive) | Epoxy/Resin, Acrylic:
3D (Additive; Stereolithography (SLA))
CP Titanium: Traditional (Subtractive)
Ti-6Al-4V: 3D (Additive; Selective Laser Melting)
Polyamide: 3D (Additive; Selective Laser Sintering) |
| Patient-specific
configuration? | Yes | Yes |
| Provided for single-
use? | Yes | Yes |
| Provide sterile? | No | No |
| Sterilization
Method | Steam Sterilization | Steam Sterilization |
| Recommended
Temporary Screw
Diameter | 1.5mm-2.1mm | 2.3mm - 3.2mm |
| Recommended
Temporary Screw
Length | 5mm-22mm | 7mm -17 mm |
| Recommended
Temporary Screw
Style | Drill-Free, Tapping-Free | MaxDrive (Drill-Free,
non-locking, locking) |
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K211614 Page 8 of 13
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Image /page/11/Picture/1 description: The image contains the word "centermed" in a stylized, sans-serif font. The word is in a dark red color. There is a horizontal line above the word, and the registered trademark symbol is to the right of the word.
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### 6 Device Types and Functions
Table 2 lays out the types, materials, and functions of the various devices offered in the CenterMed Patient Matched ASP System.
| | | Table 2: Types and Functions of CenterMed Patient Matched Devices | | | |
|--|--|-------------------------------------------------------------------|--|--|--|
|--|--|-------------------------------------------------------------------|--|--|--|
| Category | Material | Function |
|-------------------|-----------------------------------|-----------------------------------------------------------------|
| Anatomical Models | • PA-12 | • Visual representation of patient's
bone pre and/or post-op |
| Cutting Guide | • PA-12
• 316L Stainless Steel | • Cutting reconstructive bone |
#### 7 Non-clinical Performance Data
The following non-clinical performance testing was performed as supportive evidence to demonstrate substantial equivalence:
- Mechanical testing .
- Dimensional testing .
- . Wear debris testing
- Biocompatibility testing .
- Sterilization testing ●
- Software validation ●
Table 3 shows an overview of the testing performed on surgical guides, and validation testing performed on the COTS software.
| Test performed | Test
description/Guidelines | Conclusion | Safety and Efficacy
Confirmed | |
|------------------------------|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-----------|
| Mechanical testing | ISO 178:2019 | The results showed that the
sterilized and aged test
specimens met the pre-
defined acceptance criteria:
maintain 85% of initial
bending strength. The test
specimens used for bending
testing were designed and | Yes | |
| 510(k) Summary | |…
---
**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PBF/K211614](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PBF/K211614)
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