510(k) · Cleared
Recalled · Class II · 2021Bone Screws 6.5mm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lima Corporate S.P.A. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jan 4, 2018 as substantially equivalent to K112898 (Lima Corporate S.P.A., 2012) and 11 other predicates after a 143-day review. Its family tree reaches back 14 generations to 1991. 1 of the 231 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jan 4, 2018
- Review
- 143 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 2
- Predicates
- 12
Its longest line of descent runs back 14 generations to K911686 (1991). 229 ancestors in all, the oldest K790987 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 231 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 10 generations between
- 3 generations backK120174 Deput Delta Xtend Reverse ShoulderDepuy France · 2012 · Recalled
- 2 generations backK133349 SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014
- 1 generation backK161120 SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A. · 2017
- This deviceK172456 Bone Screws 6.5mmLima Corporate S.P.A. · 2018
- Descendant · cites it directly · 0 of its ownK183042 SMR Lateralized Connectors with screwsLima Corporate S.P.A. · 2019
Show all 14 generations
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 13 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 12 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 11 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 10 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 9 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 7 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 6 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 5 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 4 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 3 generations backK120174 Deput Delta Xtend Reverse ShoulderDepuy France · 2012 · Recalled
- 2 generations backK133349 SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014
- 1 generation backK161120 SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A. · 2017
- This deviceK172456 Bone Screws 6.5mmLima Corporate S.P.A. · 2018
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulderdirect predicate · 2008
Most influential descendants
Showing 1 of 1 · See all- K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −13 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −12 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −10 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −9 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −7 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −6 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −5 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −4 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −3 | K120174 | Deput Delta Xtend Reverse Shoulder | Depuy France | 2012 | 2 |
| −2 | K133349 | SMR TT Metal Back Glenoid | Lima Corporate S.P.A. | 2014 | — |
| −1 | K161120 | SMR TT Metal Back Glenoid, Bone Graft instruments | Lima Corporate S.P.A. | 2017 | — |
| 0 (this device) | K172456 | Bone Screws 6.5mm | Lima Corporate S.P.A. | 2018 | — |
| +1 | K183042 | SMR Lateralized Connectors with screws | Lima Corporate S.P.A. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1981 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 3 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 18 | 0 |
| 1995 | 18 | 0 |
| 1996 | 14 | 0 |
| 1997 | 7 | 0 |
| 1998 | 11 | 0 |
| 1999 | 11 | 0 |
| 2000 | 19 | 0 |
| 2001 | 11 | 0 |
| 2002 | 3 | 0 |
| 2003 | 7 | 0 |
| 2004 | 9 | 0 |
| 2005 | 10 | 0 |
| 2006 | 7 | 0 |
| 2007 | 9 | 0 |
| 2008 | 7 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (12)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112898 | Delta TT Cups, Delta TT Liners, Bone ScrewsSummary page 6…rther stability to the Delta TT acetabular cups and to the metal back glenoid of the SMR Shoulder System in reverse shoulder configuration. The Delta TT acetabular cups (K112898, K141395) are acetabular components intended for uncemented fixation; screw holes present in the Delta TT cups allow optional add… | 2012 |
| * | K141395 | Delta TT Acetabular SystemSummary page 6…bility to the Delta TT acetabular cups and to the metal back glenoid of the SMR Shoulder System in reverse shoulder configuration. The Delta TT acetabular cups (K112898, K141395) are acetabular components intended for uncemented fixation; screw holes present in the Delta TT cups allow optional additional f… | 2014 |
| * | K110598 | SMR Reverse Shoulder SystemSummary page 6…les present in the Delta TT cups allow optional additional fixation of the cup to the bone using 6.5mm diameter bone screws. The SMR Shoulder System metal back glenoids (K110598, K113254, K133349, K161120, K163397) are components intended to be implanted into a hole drilled in the glenoid cavity. The metal… | 2011 |
| * | K113254 | SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsSummary page 6…nt in the Delta TT cups allow optional additional fixation of the cup to the bone using 6.5mm diameter bone screws. The SMR Shoulder System metal back glenoids (K110598, K113254, K133349, K161120, K163397) are components intended to be implanted into a hole drilled in the glenoid cavity. The metal back gle… | 2012 |
| * | K133349 | SMR TT Metal Back GlenoidSummary page 6…Delta TT cups allow optional additional fixation of the cup to the bone using 6.5mm diameter bone screws. The SMR Shoulder System metal back glenoids (K110598, K113254, K133349, K161120, K163397) are components intended to be implanted into a hole drilled in the glenoid cavity. The metal back glenoid can… | 2014 |
| * | K161120 | SMR TT Metal Back Glenoid, Bone Graft instrumentsSummary page 6…cups allow optional additional fixation of the cup to the bone using 6.5mm diameter bone screws. The SMR Shoulder System metal back glenoids (K110598, K113254, K133349, K161120, K163397) are components intended to be implanted into a hole drilled in the glenoid cavity. The metal back glenoid can be used i… | 2017 |
| * | K163397 | SMR Hybrid Glenoid SystemSummary page 6…ow optional additional fixation of the cup to the bone using 6.5mm diameter bone screws. The SMR Shoulder System metal back glenoids (K110598, K113254, K133349, K161120, K163397) are components intended to be implanted into a hole drilled in the glenoid cavity. The metal back glenoid can be used in both an… | 2017 |
| * | K091508 | Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular SystemSummary page 9…Acetabular System (Limacorporate, K112898, K141395) SMR Shoulder System (Limacorporate, K110598, K113254, K133349, K161120, K163397) Continuum Acetabular System (Zimmer, K091508) Comprehensive Reverse Shoulder System (Biomet, K080642, K113121) Aequalis PerFORM Reversed (Tornier, K161742) ReUnion RSA Should… | 2009 |
| * | K080642 | Comprehensive Reverse ShoulderSummary page 9…Shoulder System (Limacorporate, K110598, K113254, K133349, K161120, K163397) Continuum Acetabular System (Zimmer, K091508) Comprehensive Reverse Shoulder System (Biomet, K080642, K113121) Aequalis PerFORM Reversed (Tornier, K161742) ReUnion RSA Shoulder System (Stryker, K161863) Comparable Features to Pr… | 2008 |
| * | K113121 | Comprehensive Reverse ShoulderSummary page 9…System (Limacorporate, K110598, K113254, K133349, K161120, K163397) Continuum Acetabular System (Zimmer, K091508) Comprehensive Reverse Shoulder System (Biomet, K080642, K113121) Aequalis PerFORM Reversed (Tornier, K161742) ReUnion RSA Shoulder System (Stryker, K161863) Comparable Features to Predicate D… | 2011 |
| * | K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidSummary page 9…349, K161120, K163397) Continuum Acetabular System (Zimmer, K091508) Comprehensive Reverse Shoulder System (Biomet, K080642, K113121) Aequalis PerFORM Reversed (Tornier, K161742) ReUnion RSA Shoulder System (Stryker, K161863) Comparable Features to Predicate Device(s) The new lengths of 6.5mm bone screws… | 2016 |
| * | K161863 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Summary page 9…tem (Zimmer, K091508) Comprehensive Reverse Shoulder System (Biomet, K080642, K113121) Aequalis PerFORM Reversed (Tornier, K161742) ReUnion RSA Shoulder System (Stryker, K161863) Comparable Features to Predicate Device(s) The new lengths of 6.5mm bone screws are identical in design, diameter, material, m… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183042 | SMR Lateralized Connectors with screws | 2019 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 1, 2021 | Class II | Z-0159-2022 | Mixed-up of materials/components | There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included. |
| Oct 1, 2021 | Class II | Z-0160-2022 | Mixed-up of materials/components | There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 71 of the 229 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K183042 (Lima Corporate S.P.A., 2019) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K112898.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to: • non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; • inflammatory degenerative joint disease such as rheumatoid arthritis; • treatment of acute…
Read the full statement (415 words)
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.
The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:
• non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• revision of a failed primary implant;
• cuff tear arthropathy (CTA Heads only);
• glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR Hybrid Glenoid only).
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient’s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The Hybrid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.
The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.
In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.
On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.
The Delta TT Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
• Rheumatoid arthritis;
• Post-traumatic arthritis,
• Correction of functional deformity;
• Fractures, dislocation of the hip and unsuccessful cup arthroplasty.
Revisions in cases of good remaining bone stock.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172456: Bone Screws 6.5mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172456
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026