# K993073: Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030

- Pathway: 510(k) (Traditional)
- Applicant: Bionx Implants, Ltd.
- Decided: Dec 6, 1999 after 83 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K933738 (1994). 21 ancestors in all.
16 later devices descend from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955733: Hyloc Interference Screw (Cannulated)/(Non-Cannulated), Depuy, Inc. (1996) Summary page 1.
- K981670: Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable Interference Screw, Depuy, Inc. (1998) Summary page 1.
- K982662: Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable Interference Screw, DePuy Orthopaedics, Inc. (1998) Summary page 1.
- K933719: Bioscrew Absorbable Interference Screw, Linvatec Corp. (1994) Summary page 1.
- K952831: Bioscrew Absorbable Interference Screw, Linvatec Corp. (1995) Summary page 1.
- K973758: Bioscrew Absorbable Interference Srew, Linvatec Corp. (1998) Summary page 1.
- K943249: Bioabsorbable Interference Screw, Instrument Makar, Inc. (1995) Summary page 1.
- K982497: Arthrotek Interference Screw, Biomet, Inc. (1998). Our OCR of the scanned summary read K982496, FDA’s number for Quadrature Lower Extremity Coil, Model # 473SI-42D (Medical Advances, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Biomet, Inc. Arthrotek Interference Screw”.
- K971358: Bio-Interference Screw, 7 MM, 8 MM, 9 MM, Arthrex, Inc. (1997) Summary page 2.
- K970829: Phusis Absorbable Interference Screw, Tornier (1998) Summary page 2.
- K954246: Acufex Endofix Absorbable Interference Screw, Acufex Microsurgical, Inc. (1996) Summary page 2.
- K984320: Bioabsorbable Interference Screws, Smith & Nephew, Inc. (1999) Summary page 2.
- K983592: Sulzer Orthopedics Sysorb Interference Screws, Sulzer Orthopedics, Inc. (1999) Summary page 2.

## Most influential descendants
- K032894: Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, (2004), 15 descendants of its own
- K052080: Matryx Interference Screw (2005), 13 descendants of its own
- K101100: Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 (2010), 5 descendants of its own
- K063588: Matryx Interference Screw, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5 (2007), 3 descendants of its own
- K170501: CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver (2017), 2 descendants of its own

## Indications for use
The SmartScrew ACL™ is intended for use in interference fixation of bone-patellar tendon — bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions. The SmartScrew ACL™ is not intended for use in and is contraindicated for 1) cruciate ligament reconstructions, which would not be appropriate for fixation with metallic screws and 2) situations, where intra-articular replacement is otherwise contraindicated, e.g., active or potential infection and where patient cooperation cannot be guaranteed (e.g., alcoholism).

Source page: https://510kreport.com/device/K993073
Methodology: https://510kreport.com/methodology