EasyClip and EasyClip Xpress
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Stryker GmbH
Identity
- Trade Name
- EASYCLIP EUDAMEDFDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- EASYCLIP INSTRUMENTS - INSTRUMENTATION SLEEVES - CLASS I - REUSABLE - NON STERILE EUDAMEDFixed staple drill guide head - Size 12 FDA UDI
- Model / Reference
- 460016R2012 EUDAMEDFDA UDI08858251002566T9 EUDAMED
- Description
- Fixed staple drill guide head - Size 12 FDA UDI
Identifiers
- Catalog Number
- 460016R2012 FDA UDI
- Primary DI / UDI-DI
- 07613252257141 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858251002566T9 EUDAMED
- Direct Marketing DI
- 07613252257141 EUDAMED
- 510(k) Number
- K210582 FDA 510(k)
- FDA Product Code
- JDR FDA 510(k)LXH FDA UDI
- EMDN Code
- P091280 OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES EUDAMED
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)888.4540 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The EasyClip and EasyClip Xpress are orthopedic bone fixation staples designed for securing bone fragments or plates in surgical applications. Their superelastic material provides a constant compressive force, ensuring stable fixation during the healing process.
These devices are supplied sterile and intended for single-use. They are classified under the product code JDR and have received FDA 510(k) clearance and MDR authorization. The EasyClip Xpress variant is optimized for expedited application, while both variants are compatible with standard orthopedic surgical settings.
Frequently asked questions
What is the primary purpose of the EasyClip and EasyClip Xpress in orthopedic surgery?
The EasyClip and EasyClip Xpress are designed to secure bone fragments or plates during surgical procedures, providing stable fixation through a constant compressive force. Their superelastic material ensures reliable holding power throughout the healing process, making them suitable for applications where secure bone alignment is critical.
Are the EasyClip and EasyClip Xpress meant for reuse in surgical settings, or are they single-use devices?
Both the EasyClip and EasyClip Xpress are explicitly intended for single-use only. They are supplied sterile to ensure patient safety and clinical efficacy, adhering to best practices for orthopedic fixation devices.
How do the EasyClip Xpress and EasyClip differ in terms of application speed or design?
The EasyClip Xpress is specifically optimized for expedited application, meaning it is engineered to be applied more quickly than the standard EasyClip. While both share the same core function of securing bone fragments or plates, the Xpress variant streamlines the surgical workflow without compromising fixation stability.
What regulatory pathways have the EasyClip and EasyClip Xpress undergone, and what does that mean for their use?
The EasyClip and EasyClip Xpress have received FDA 510(k) clearance under the Traditional review pathway, with a decision code of SESE (Substantially Equivalent). They are also MDR-authorized, indicating compliance with European medical device regulations. This means they meet established safety and performance standards for orthopedic fixation devices in both the U.S. and EU markets.
Are there different sizes or models available for the EasyClip and EasyClip Xpress, and how might a clinician choose between them?
While the provided data does not specify exact sizes or models, the distinction lies between the standard EasyClip and the EasyClip Xpress, which is optimized for faster application. Clinicians would typically select based on surgical needs—whether prioritizing speed (Xpress) or standard performance (EasyClip)—while ensuring compatibility with their specific orthopedic fixation requirements.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EasyClip - Stryker, PDF EasyClip Xpress | Operative Technique - Stryker, EasyClip® and EasyClip® Xpress by Stryker GmbH | FDA 510(k) Summary
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K210582 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker GmbH
Sources (3)
- FDA 510(k) K210582 24 fields · synced Sep 30, 2026
- FDA UDI 97ff3245-c38a-42b1-87f4-4c562f7816b6 35 fields · synced May 29, 2026
- EUDAMED d8010b16-8364-4a8d-a6b9-d2d56d15a2c4 61 fields · synced Sep 17, 2026