SKaffold
SKaffold Impress Bone Void Filler Mixing and Delivery System
2manufacturers in China registered for this device type
10catalogue numbers in this listing
6510(k) clearances naming this product code
24recalls on this code
Who Else Makes It
Concentrated in Shanghai (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Allgens Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 1 |
Record
| Listed by | Skeletal Kinetics, LLC, United States |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| Record published | 2015-10-30 |
| Record revised | 2021-03-22 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
| Sizes | Total volume 3 to 25 ml |
| Distribution end date | 2021-01-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SKMX-FL10 | Total Volume 10 ml | Withdrawn |
| SKMX-IM10 | Total Volume 10 ml | Withdrawn |
| SKMX-FL05 | Total Volume 5 ml | Withdrawn |
| SKMX-FL03 | Total Volume 3 ml | Withdrawn |
| SKAF-FL10 | Total Volume 10 ml | Withdrawn |
| SKAF-IM10 | Total Volume 10 ml | Withdrawn |
| SKAF-IM05 | Total Volume 5 ml | Withdrawn |
| SKAF-FL05 | Total Volume 5 ml | Withdrawn |
| SKMX-IM05 | Total Volume 5 ml | Withdrawn |
| SKAF-IM25 | Total Volume 25 ml | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Synthacer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 360 |
| Syntricer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 357 |
| Biosorb | S.B.M | 65 |
| MagnetOs | Kuros Biosciences B.V | 61 |
| BioSet® | Rti Surgical, Inc. | 47 |
| Bicera® Resorbable Bone Substitute | Wiltrom Corporation Limited | 41 |
| GRAFTON®and Grafton PLUS®Demineralized Bone Matrix (DBM) | Medtronic Sofamor Danek, Inc. | 40 |
| Bicera® Resorbable Bone Substitute | Wiltrom Co., Ltd. (Chutung) | 39 |
| ChronOS | Synthes Gmbh | 39 |
| Synthacer/Syntricer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 36 |
| Inion BioRestore™ | Inion OY | 35 |
| Resorba Synthetic Bone | Biomatlante | 35 |
Showing 12 of 750. All products under Filler, Bone Void, Calcium Compound
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K132211 | 2014-08-04 |
| K120354 | 2013-03-21 |
| K112383 | 2012-02-07 |
| K100986 | 2010-07-20 |
| K051123 | 2005-06-03 |
| K030554 | 2003-05-20 |
Recalls
24 of these are Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 62 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 379 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 35 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 217 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 101 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 442 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 20 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 491 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 41 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 86 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 121 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 150 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 375 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 12 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 60 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 1 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 184 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 1053 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 15 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 88 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 21 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 4 | 2021-02-24 |
| 2020-04-06 | Class II | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include inc | 40 | 2021-02-24 |
| 2015-05-29 | Class II | No Marketing Application | Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler. | 67 kits | 2015-07-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.