# K112885: Zimmer Plates and Screws System Screws Only

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Dec 19, 2011 after 80 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K000684 (2000). 11 ancestors in all.
135 later devices descend from it; 4 cite it directly.
1 of 147 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090047: Synthes (Usa) 1.5MM Mini Fragment LCP System, Synthes (Usa) (2009) Summary page 1.
- K952272: TI. Alloy 2.0 MM Cortex Screw, Synthes (Usa) (1995) Summary page 1.
- K063303: Universal Locking System, 2.7MM Plates & Screws, Zimmer, Inc. (2006) Summary page 1.
- K060710: Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws, Zimmer, Inc. (2006) Summary page 1.
- K082527: Zimmer Universal Locking System: 3.5 MM Locking Plates and Screws, Zimmer, Inc. (2008) Summary page 1.
- K061621: Synthes (Usa) 6.5 MM Cancellous Screws, Synthes (Usa) (2006) Summary page 1.
- K003496: Cannulated Screw System, Pioneer Surgical Technology (2001) Summary page 1.
- K983265: Depuy Ace Composite Locking Nut, Depuy Ace Medical Co. (1998) Summary page 1.

## Most influential descendants
- K143039: CrossRoads Screw System (2015), 79 descendants of its own
- K162825: CAPTIVATE™ Compression Screws (2017), 74 descendants of its own
- K171651: Excelsius GPS (2017), 69 descendants of its own
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 descendants of its own
- K124027: Monster Screw System (2013), 41 descendants of its own

## Recalls of this device
- May 4, 2016 · Class II · Z-1677-2016: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Jan 11, 2016 · Class II · Z-1108-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Jan 11, 2016 · Class II · Z-1111-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Jan 11, 2016 · Class II · Z-1116-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Jan 11, 2016 · Class II · Z-1102-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Jul 22, 2014 · Class II · Z-2247-2014: Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
- Jul 22, 2014 · Class II · Z-2249-2014: Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
- Jul 22, 2014 · Class II · Z-2251-2014: Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
- Jul 22, 2014 · Class II · Z-2246-2014: Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
- Jul 22, 2014 · Class II · Z-2248-2014: Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
- Jul 22, 2014 · Class II · Z-2245-2014: Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
- Jul 22, 2014 · Class II · Z-2250-2014: Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
- Jul 22, 2014 · Class II · Z-2244-2014: Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
- Oct 11, 2013 · Class II · Z-1040-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag
- Oct 11, 2013 · Class II · Z-1042-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag

## Indications for use
Temporary internal fixation devices are designed to stabilize fractures during the normal healing process.

Source page: https://510kreport.com/device/K112885
Methodology: https://510kreport.com/methodology