Instrument
Secur-FIT Acetabular Instrumentationperipheral Screw Drill Guide
9manufacturers in China registered for this device type
120catalogue numbers in this listing
2510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | LWJ |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| 510(k) | K211703 |
| Record published | 2016-09-24 |
| Record revised | 2024-05-10 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Lumen/inner diameter 22 to 52 mm; outer diameter 47 to 68 mm; length 15 to 40 mm |
| Distribution end date | 2023-10-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2250-32I | Degree: 10.0 Degree | In distribution |
| 2240-22E | Degree: 0.0 Degree | In distribution |
| 3200-52H | Alpha Code: H | In distribution |
| 1030-2248 | Outer Diameter 48.0 mm | In distribution |
| I-H1672SL11 | In distribution | |
| 2230-28I | Alpha Code: I | In distribution |
| 2240-36G | Degree: 0.0 Degree | In distribution |
| 2240-36J | Degree: 0.0 Degree | In distribution |
| 2210-28E | Degree: 10.0 Degree | In distribution |
| 1440-1040 | In distribution | |
| 1020-1400 | In distribution | |
| 2107-3317 | Diameter: 3.3 Millimeter | In distribution |
| 2107-5003 | In distribution | |
| 1110-0608 | In distribution | |
| 8000-7708 | Size: 8 | In distribution |
| 2260-28H | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2208-2046A | Diameter: 46.0 Millimeter | In distribution |
| 0580-35 | Offset: 35.5 Millimeter | In distribution |
| 1030-2850 | Outer Diameter 50.0 mm | In distribution |
| 2107-3340 | Diameter: 3.3 Millimeter | In distribution |
| 2250-28I | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2102-0472 | Diameter: 72.0 Millimeter | In distribution |
| 2102-0453 | Diameter: 53.0 Millimeter | In distribution |
| 1601-38132 | Diameter: 38.0 Millimeter | In distribution |
| 6266-5-005 | Size: SM | In distribution |
| 1440-1070 | In distribution | |
| 2260-28I | Alpha Code: I | In distribution |
| 2102-0441 | Diameter: 41.0 Millimeter | In distribution |
| 0581-1-374 | Taper Connection: V40? | In distribution |
| 2250-32D | Lumen/Inner Diameter 32.0 mm | In distribution |
| 1020-5105 | Size: 5 | In distribution |
| 1030-2854 | Outer Diameter 54.0 mm | In distribution |
| 1100-2897R | Taper Connection: C-TPR | In distribution |
| 2200-28C | Alpha Code: C | In distribution |
| 2210-32I | Alpha Code: I | In distribution |
| I-H2108PR50 | Diameter: 50.0 Millimeter | In distribution |
| 2102-0474 | Diameter: 74.0 Millimeter | In distribution |
| 2200-32H | Lumen/Inner Diameter 32.0 mm | In distribution |
| I-H2122AD00 | In distribution | |
| 2230-28H | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2270-28G | Alpha Code: G | In distribution |
| 1090-3260 | Diameter: 60.0 Millimeter | In distribution |
| 2208-4073 | Diameter: 73.0 Millimeter | In distribution |
| 1020-2735 | Degree: 127.0 Degree | In distribution |
| 2208-4076 | Diameter: 76.0 Millimeter | In distribution |
| 2240-22D | Degree: 0.0 Degree | In distribution |
| 0580-4450-2 | Size: 2 | In distribution |
| 0580-330-0 | Offset: 33.0 Millimeter | In distribution |
| 2208-4046S | Diameter: 46.0 Millimeter | In distribution |
| 1020-5209 | Size: 9 | In distribution |
| 1030-2656 | Outer Diameter 56.0 mm | In distribution |
| 2250-28J | Degree: 10.0 Degree | In distribution |
| 2208-6059R | Outer Diameter 59.0 mm | In distribution |
| 2208-4061 | Diameter: 61.0 Millimeter | In distribution |
| 2240-28D | Lumen/Inner Diameter 28.0 mm | In distribution |
| 1100-1340S | Length 40.0 mm | In distribution |
| 2208-6059L | Outer Diameter 59.0 mm | In distribution |
| 2208-2048A | Diameter: 48.0 Millimeter | In distribution |
| 2107-3318 | In distribution | |
| 1150-2368 | Outer Diameter 68.0 mm | In distribution |
| 6090-4-320 | In distribution | |
| 2230-28J | Lumen/Inner Diameter 28.0 mm | In distribution |
| 1030-2652 | Lumen/Inner Diameter 26.0 mm | In distribution |
| 3200-36C | Lumen/Inner Diameter 36.0 mm | In distribution |
| 2260-28C | Alpha Code: C | In distribution |
| 2210-22D | Alpha Code: D | In distribution |
| I-H2108PR62 | Diameter: 62.0 Millimeter | In distribution |
| 0930-6-000 | In distribution | |
| 1212-0015 | Length 15.0 mm | In distribution |
| I-H1862HB06 | Size: 6 | In distribution |
| 6264-8-244R | Taper Connection: V40? | In distribution |
| 2199-2032 | Diameter: 32.0 Millimeter | In distribution |
| 2200-36H | Degree: 0.0 Degree | In distribution |
| 1235-V-1120 | Offset: 12.0 Millimeter | In distribution |
| 2260-32G | Alpha Code: G | In distribution |
| 1100-4425R | Taper Connection: C-TPR | In distribution |
| 1030-3256 | Lumen/Inner Diameter 32.0 mm | In distribution |
| 1111-1002 | Size: MED | In distribution |
| 6264-8-736R | Offset: 7.5 Millimeter | In distribution |
| 1020-5203 | Size: 3 | In distribution |
| 2111-3044 | Diameter: 44.0 Millimeter | In distribution |
| 1110-0305 | In distribution | |
| 1020-1600 | In distribution | |
| 8000-7706 | Size: 6 | In distribution |
| 2208-6065L | Outer Diameter 65.0 mm | In distribution |
| 1030-2654 | Lumen/Inner Diameter 26.0 mm | In distribution |
| 1020-5145 | Size: 4.5 | In distribution |
| 2210-22J | Degree: 10.0 Degree | In distribution |
| 1119-3000 | In distribution | |
| 2210-26I | Alpha Code: I | In distribution |
| 1235-0-864M | In distribution | |
| 2260-32F | Alpha Code: F | In distribution |
| I-H2154RG56 | In distribution | |
| 1150-2353 | Outer Diameter 53.0 mm | In distribution |
| 2210-26H | Degree: 10.0 Degree | In distribution |
| 4845-7-973 | In distribution | |
| 2210-36J | Lumen/Inner Diameter 36.0 mm | In distribution |
| 8000-7700 | Size: 0 | In distribution |
| 6825-9-947 | Outer Diameter 47.0 mm | In distribution |
| 1100-1335S | Taper Connection: C-TPR | In distribution |
| 2111-3040 | Diameter: 40.0 Millimeter | In distribution |
| 2107-1000 | In distribution | |
| I-H1862HB00 | Size: 0 | In distribution |
| 2111-0000B | In distribution | |
| 1090-3256 | Diameter: 56.0 Millimeter | In distribution |
| 1090-2850 | Diameter: 50.0 Millimeter | In distribution |
| 1601-1010A | Size: 10 | In distribution |
| 1113-1001 | Size: SM | In distribution |
| I-H0659HA62 | Diameter: 62.0 Millimeter | Withdrawn |
| I-H0354HA00 | Withdrawn | |
| I-H08452053 | Diameter: 53.0 Millimeter | Withdrawn |
| I-H0659HA42 | Diameter: 42.0 Millimeter | Withdrawn |
| I-H0669HA32 | Diameter: 32.0 Millimeter | Withdrawn |
| I-H0659HA65 | Diameter: 65.0 Millimeter | Withdrawn |
| I-H1157136H | Alpha Code: H | Withdrawn |
| I-H1552HA40 | Length 40.0 mm | Withdrawn |
| I-H0659HA51 | Diameter: 51.0 Millimeter | Withdrawn |
| I-H1961H365 | Taper Connection: V40? | Withdrawn |
| I-H0659HA56 | Diameter: 56.0 Millimeter | Withdrawn |
| I-H0659HA70 | Diameter: 70.0 Millimeter | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Iconacy i-Hip | Iconacy Orthopedic Implants, LLC | 154 |
| ZMR® | Zimmer, Inc. | 129 |
| Restoration | Howmedica Osteonics Corp | 66 |
| U2 Hip Stem | United Orthopedic Corp. | 60 |
| Trinity Acetabular Hip System | Corin Limited | 58 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Exactech, Inc. | 51 |
| Omnifit | Howmedica Osteonics Corp | 48 |
| Novation | Exactech, Inc. | 48 |
| Endo-Model SL Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 46 |
| Trident | Howmedica Osteonics Corp | 43 |
| Kinectiv® | Zimmer, Inc. | 41 |
| Aesculap | Aesculap AG | 38 |
Showing 12 of 131. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K023692 | 2003-03-20 |
| K993601 | 1999-11-16 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| 2009-06-18 | Not classified | Process control | Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width. | 13 total, both products. | 2012-08-27 |
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.