Arthrex®
HD Scorpion LNT System, 4.75 BC KL SWLCK
2manufacturers in China registered for this device type
545catalogue numbers in this listing
46510(k) clearances naming this product code
7recalls on this code
Who Else Makes It
All of them in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Arthrex, Inc., United States |
|---|---|
| FDA product code | MAI |
| Device type | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Record published | 2017-02-15 |
| Record revised | 2026-06-29 (version 35) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 5, box of 3 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AR-1349L | In distribution | |
| AR-1366-48 | In distribution | |
| AR-1927KPS-1 | In distribution | |
| AR-1941BC | In distribution | |
| AR-1662BCC-7 | In distribution | |
| AR-1365NS-525 | In distribution | |
| AR-1927BCFT-45 | In distribution | |
| AR-5035TB-09 | In distribution | |
| AR-3007B-14 | In distribution | |
| AR-2324BCCT-1 | In distribution | |
| AR-1356NS | In distribution | |
| AR-2238B | In distribution | |
| AR-1594 | In distribution | |
| AR-1922BC | In distribution | |
| AR-2600SBS-5 | In distribution | |
| AR-2324BCC-1 | In distribution | |
| AR-5035P-12 | In distribution | |
| AR-1586FRB-07 | In distribution | |
| AR-1400 | In distribution | |
| AR-1934BF-1 | In distribution | |
| AR-2324KBCSP | In distribution | |
| AR-1927BCF-1 | In distribution | |
| AR-1934PS-2-1 | In distribution | |
| AR-1926B-1 | In distribution | |
| AR-1934BNF-1 | In distribution | |
| AR-1322BCST-2-1 | In distribution | |
| AR-1366-32 | In distribution | |
| AR-1665BCSLSN-39 | In distribution | |
| AR-1938BC | In distribution | |
| AR-8929 | In distribution | |
| AR-2323KBCSP | In distribution | |
| AR-1380TC | In distribution | |
| AR-1586RB-08 | In distribution | |
| AR-5090AB | In distribution | |
| AR-1365-35 | In distribution | |
| AR-1363 | In distribution | |
| AR-1662BC-7 | In distribution | |
| AR-1380TB | In distribution | |
| AR-2324PCTT-1 | In distribution | |
| AR-1355 | In distribution | |
| AR-5035TB-10 | In distribution | |
| AR-1938PSS-1 | In distribution | |
| AR-2324BCM-1 | In distribution | |
| AR-2600SBS-2 | In distribution | |
| AR-1381T | In distribution | |
| AR-2324BCC-2 | In distribution | |
| AR-1586RB-06 | In distribution | |
| AR-1366NS-28 | In distribution | |
| AR-1943BC | In distribution | |
| AR-7285 | In distribution | |
| AR-1662BC-7-1 | In distribution | |
| AR-1934BCF-24 | In distribution | |
| AR-2323KBCSP-1 | In distribution | |
| AR-2600FSF-3 | In distribution | |
| AR-2324PSLC | In distribution | |
| AR-1370TC | In distribution | |
| AR-4030C-12 | In distribution | |
| AR-1665KBCSLSN | In distribution | |
| AR-1927BCF-45-1 | In distribution | |
| AR-1662BCC-7-1 | In distribution | |
| AR-1927BCT-1 | In distribution | |
| AR-1934BCFT-2-1 | In distribution | |
| AR-1366NS-34 | In distribution | |
| AR-1927BCNF-1 | In distribution | |
| AR-4020C-08 | In distribution | |
| AR-1392T | In distribution | |
| AR-5028B-09 | In distribution | |
| AR-1586RC-09 | In distribution | |
| AR-2923BC-1 | In distribution | |
| AR-1390H-30 | In distribution | |
| AR-1400T | In distribution | |
| AR-1586FR-07 | In distribution | |
| AR-1934BCFT-2 | In distribution | |
| AR-2324KBC-1 | In distribution | |
| AR-5522 | In distribution | |
| AR-1926BCSP | In distribution | |
| AR-1370E | In distribution | |
| AR-8928BCJ-CP | In distribution | |
| AR-1366-42 | In distribution | |
| AR-1365-30 | In distribution | |
| AR-1366-40 | In distribution | |
| AR-1934BCT-2 | In distribution | |
| AR-2323BSLM-1 | In distribution | |
| AR-1392E | In distribution | |
| AR-1365-475 | In distribution | |
| AR-1404TB | In distribution | |
| AR-9928P-CP | In distribution | |
| AR-2324PCT | In distribution | |
| AR-1366-30 | In distribution | |
| AR-1365-40 | In distribution | |
| AR-1357B | In distribution | |
| AR-1391T | In distribution | |
| AR-1363L | In distribution | |
| AR-1402 | In distribution | |
| AR-1586R-09 | In distribution | |
| AR-1938BCS-1 | In distribution | |
| AR-1390 | In distribution | |
| AR-1401 | In distribution | |
| AR-1927BCF-45 | In distribution | |
| AR-8982BCT | In distribution | |
| AR-1586RB-07 | In distribution | |
| AR-1922BCM | In distribution | |
| AR-2324KBC | In distribution | |
| AR-8934BCNF-1 | In distribution | |
| AR-1938BCH-1 | In distribution | |
| AR-5028C-11 | In distribution | |
| AR-5035P-10 | In distribution | |
| AR-2325BCC | In distribution | |
| AR-1370H-35 | In distribution | |
| AR-1366-38 | In distribution | |
| AR-5028P-12 | In distribution | |
| AR-2236B | In distribution | |
| AR-1375E | In distribution | |
| AR-1380 | In distribution | |
| AR-8980P | In distribution | |
| AR-1391 | In distribution | |
| AR-4030C-11 | In distribution | |
| AR-1365NS-25 | In distribution | |
| AR-2324BSLC | In distribution | |
| AR-2324PSLC-2-1 | In distribution | |
| AR-1941PS | In distribution | |
| AR-1365NS-275 | In distribution | |
| AR-1380C | In distribution | |
| AR-1390E | In distribution | |
| AR-1934BCF | In distribution | |
| AR-2324KPSP | In distribution | |
| AR-1351LBK-CP | In distribution | |
| AR-1938PS | In distribution | |
| AR-1366-52 | In distribution | |
| AR-1586LB-07 | In distribution | |
| AR-7286 | In distribution | |
| AR-1789J-CP | In distribution | |
| AR-1365NS-60 | In distribution | |
| AR-2924BCH | In distribution | |
| AR-2326BCC | In distribution | |
| AR-1934PS-1 | In distribution | |
| AR-1366NS-36 | In distribution | |
| AR-4212B-16 | In distribution | |
| AR-2923BCS | In distribution | |
| AR-2324BSLC-1 | In distribution | |
| AR-1356 | In distribution | |
| AR-1927BCT | In distribution | |
| AR-1936PS | In distribution | |
| AR-1688-CP | In distribution | |
| AR-1365NS-50 | In distribution | |
| AR-2324KBCCTT-1 | In distribution | |
| AR-4208B-14 | In distribution | |
| AR-2324KPCTT-1 | In distribution | |
| AR-1365-55 | In distribution | |
| AR-1365-25 | In distribution | |
| AR-1927BCF-475 | In distribution | |
| AR-1923BCH | In distribution | |
| AR-1662PSL-9-1 | In distribution | |
| AR-5035P-11 | In distribution | |
| AR-1366NS-26 | In distribution | |
| AR-5028C-09 | In distribution | |
| AR-2600SBS-3 | In distribution | |
| AR-1934BCF-24-2-1 | In distribution | |
| AR-8929BC-CP | In distribution | |
| AR-2323BSLC | In distribution | |
| AR-2324BSLT | In distribution | |
| AR-1366NS-50 | In distribution | |
| AR-8934BCK-1 | In distribution | |
| AR-1322BCST-2 | In distribution | |
| AR-1365-45 | In distribution | |
| AR-4030C-07 | In distribution | |
| AR-4030C-08 | In distribution | |
| AR-1586FR-10 | In distribution | |
| AR-2600SCR | In distribution | |
| AR-1390H-35 | In distribution | |
| AR-1662BC-9-1 | In distribution | |
| AR-1934PRK | In distribution | |
| AR-2324BCCS | In distribution | |
| AR-1351LK-CP | In distribution | |
| AR-1358NS | In distribution | |
| AR-2324BSLTT | In distribution | |
| AR-8980BCT | In distribution | |
| AR-5035TC-11 | In distribution | |
| AR-9927BC | In distribution | |
| AR-1586R-08 | In distribution | |
| AR-1366NS-52 | In distribution | |
| AR-1365NS-45 | In distribution | |
| AR-2325PSLC-1 | In distribution | |
| AR-1778P-CP | In distribution | |
| AR-1665BCPL | In distribution | |
| AR-1934BCT-1 | In distribution | |
| AR-1926BH-1 | In distribution | |
| AR-1934BCF-1 | In distribution | |
| AR-1926BC | In distribution | |
| AR-1380E | In distribution | |
| AR-1926BC-1 | In distribution | |
| AR-1934BF-2-1 | In distribution | |
| AR-4005B-10 | In distribution | |
| AR-2323PSLM-1 | In distribution | |
| AR-1320BCNF | In distribution | |
| AR-1662BCC-9 | In distribution | |
| AR-1936PSS | In distribution | |
| AR-2323KBCC | In distribution | |
| AR-1920B-1 | In distribution | |
| AR-1927BCF | In distribution | |
| AR-2324SLM | In distribution | |
| AR-1927BCF-3-1 | In distribution | |
| AR-2324KBCCTT | In distribution | |
| AR-1400TC | In distribution | |
| AR-1382T | In distribution | |
| AR-1401T | In distribution | |
| AR-2323BCC-1 | In distribution | |
| AR-1662PSL-8-1 | In distribution | |
| AR-1402T | In distribution | |
| AR-8980BC | In distribution | |
| AR-1936BCS | In distribution | |
| AR-1938BCH | In distribution | |
| AR-1665BCSLSN | In distribution | |
| AR-5090BB | In distribution | |
| AR-1365NS-40 | In distribution | |
| AR-2326PSLC-1 | In distribution | |
| AR-2323KBCC-1 | In distribution | |
| AR-1366NS-48 | In distribution | |
| AR-5035P-09 | In distribution | |
| AR-2324KPCTT | In distribution | |
| AR-1662PSL-9 | In distribution | |
| AR-8927BC | In distribution | |
| AR-1349LMNS | In distribution | |
| AR-1370T | In distribution | |
| AR-2323BSLC-1 | In distribution | |
| AR-1370H-30 | In distribution | |
| AR-1351LBT | In distribution | |
| AR-1927KBC-1 | In distribution | |
| AR-1586R-10 | In distribution | |
| AR-1662BCC-9-1 | In distribution | |
| AR-3007B-12 | In distribution | |
| AR-4020C-07 | In distribution | |
| AR-2324PSLM-1 | In distribution | |
| AR-1662B | In distribution | |
| AR-8928P-CP | In distribution | |
| AR-5010AB | In distribution | |
| AR-1927BCFT-45-1 | In distribution | |
| AR-1926BCSP-1 | In distribution | |
| AR-8934BCNF-00 | In distribution | |
| AR-1351L | In distribution | |
| AR-1370B | In distribution | |
| AR-1390C | In distribution | |
| AR-1662PSL-7-1 | In distribution | |
| AR-2324KPSLC | In distribution | |
| AR-1586RC-10 | In distribution | |
| AR-9928BC-DX | In distribution | |
| AR-1366NS-40 | In distribution | |
| AR-1365-325 | In distribution | |
| AR-1382 | In distribution | |
| AR-1380B | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fix2Lock | Osteonic Co., Ltd. | 118 |
| Delta | Stryker Leibinger Gmbh & Co. KG | 110 |
| Reunite Screw System | Biomet Orthopedics | 85 |
| ComposiTCP | S.B.M | 61 |
| ActivaScrew™ Interference | Bioretec Ltd. | 54 |
| Ligafix | S.B.M | 40 |
| Twinfix | Smith & Nephew, Inc. | 28 |
| Biosure | Smith & Nephew, Inc. | 27 |
| TorqLoc Interference | Bioretec Ltd. | 27 |
| FiberFIX | Nanova BIO Materials Inc | 25 |
| AlphaVent | Stryker GmbH | 23 |
| Twist AP Suture Anchors | Parcus Medical, LLC | 17 |
Showing 12 of 176. All products under Fastener, Fixation, Biodegradable, Soft Tissue
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262357 | 2026-08-07 |
| K253931 | 2026-05-28 |
| K250526 | 2025-03-14 |
| K233971 | 2024-06-04 |
| K230435 | 2023-03-17 |
| K221128 | 2022-10-05 |
| K222263 | 2022-08-26 |
| K221099 | 2022-05-13 |
| K203495 | 2021-04-19 |
| K202535 | 2020-11-18 |
| K201749 | 2020-08-21 |
| K201786 | 2020-07-30 |
| K193503 | 2020-01-15 |
| K193157 | 2019-12-12 |
| K192532 | 2019-10-19 |
| K192441 | 2019-10-17 |
| K191226 | 2019-06-11 |
| K180768 | 2018-12-14 |
| K180594 | 2018-06-22 |
| K180662 | 2018-05-22 |
| K173788 | 2018-03-01 |
| K173240 | 2018-01-16 |
| K171141 | 2017-05-04 |
| K151342 | 2016-03-24 |
| K140855 | 2014-12-18 |
| K120540 | 2012-03-20 |
| K112040 | 2011-12-15 |
| K110660 | 2011-03-31 |
| K101823 | 2011-01-07 |
| K101679 | 2010-10-22 |
| K091844 | 2009-08-28 |
| K082810 | 2009-01-23 |
| K082999 | 2008-12-30 |
| K071456 | 2008-01-17 |
| K071176 | 2007-08-03 |
| K062466 | 2006-11-29 |
| K051219 | 2005-06-29 |
| K011495 | 2001-08-01 |
| K003227 | 2001-01-08 |
| K000506 | 2000-05-01 |
| K990340 | 2000-01-28 |
| K990987 | 2000-01-13 |
| K983577 | 1999-08-13 |
| K990361 | 1999-04-14 |
| K983843 | 1999-03-12 |
| K971358 | 1997-07-09 |
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-06-14 | Class II | Under Investigation by firm | Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch. | 3985 pieces | |
| 2017-03-24 | Class II | Under Investigation by firm | Some eyelets broke from SwiveLock Anchor on insertion. | 2019-11-04 | |
| 2017-03-24 | Class II | Under Investigation by firm | Some eyelets broke from SwiveLock Anchor on insertion. | 2019-11-04 | |
| 2017-03-24 | Class II | Under Investigation by firm | Some eyelets broke from SwiveLock Anchor on insertion. | 2019-11-04 | |
| 2017-03-24 | Class II | Under Investigation by firm | Some eyelets broke from SwiveLock Anchor on insertion. | 2019-11-04 | |
| 2017-03-24 | Class II | Under Investigation by firm | Some eyelets broke from SwiveLock Anchor on insertion. | 2019-11-04 | |
| 2017-03-24 | Class II | Under Investigation by firm | Some eyelets broke from SwiveLock Anchor on insertion. | 2019-11-04 |
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.